The Rules On Genetically Modified Organisms For Contained Use And Deliberate Release Into The Environment And Market, As Well As Procedures For Monitoring

Original Language Title: Noteikumi par ģenētiski modificēto organismu ierobežotu izmantošanu un apzinātu izplatīšanu vidē un tirgū, kā arī par monitoringa kārtību

Read the untranslated law here: https://www.vestnesis.lv/ta/id/88048

 
Cabinet of Ministers Regulations No. 333 in 2004 Riga 20 April (pr. No 23, 26) rules on genetically modified organisms for contained use and deliberate release into the environment and market, as well as monitoring procedures Issued pursuant to the law "on environmental protection" in article 9, paragraph 14 i. General questions 1. establish procedures for genetically modified organisms or their components limited use, deliberate release into the environment, market penetration and widespread trade in genetically modified organisms for monitoring. 2. The genetically modified organisms are biological objects, which are able to reproduce and distribute your heredity information (also micro-organisms including viruses, viroids, animal and plant cell culture), with the exception of people in which the genetic material has been altered otherwise than it happens naturally or as a result of sexual recombination. 3. Genetically modified organisms in contained use is any action that the genetically modified organisms and genetically modified organisms cultured, stored, transferred, destroyed, disposed of or used in any other way, using specific means of containment to prevent exposure to these organisms in ecosystems and protect human health and the environment. 4. genetically modified organisms deliberate release into the environment of genetically modified organisms are or deliberate introduction of the components in the environment without the use of physical barriers or combinations with chemical or biological limits that are used to restrict genetically modified organisms with the ecosystem. 5. The genetically modified organisms are on the market of genetically modified organisms or products containing it transfer to third parties in return for payment or free of charge. 6. genetic modification of organisms if uses the following methods to modify: 6.1. nucleic acid recombination methods, which include 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 include a nucleic acid into the cells, which they naturally did not create, but able to continue reproduction; 6.2. the methods associated with the created outside the organism of heritable material in the body, including the introduction of direct, mikroinkapsulācij; 6.3. the cell and protoplast merge or hybridization methods when cells with new combinations of genetic material are formed through the merging of two or more cells remote from the systematic organism groups and using techniques that do not occur naturally.
7. genetic modification of organisms does not occur when you use the following methods: 7.1. modified fertilizācij in vitro;
7.2. natural processes-conjugation, transduction, transformation; polyploidy induction of 7.3. The above modification methods do not use recombinant nucleic acid molecules or genetically modified organisms created using 5.1 the methods referred to in point.
8. the rules do not apply to: 8.1 the genetic modification occurs, applying one of the following methods, if it is not used in recombinant nucleic acid molecules or genetically modified organisms: 8.1.1. mutaģenēz; 8.1.2. various species of the prokaryotic cell or protoplast fusion, which results in the exchange of genetic material; 8.1.3. eukaryotic cells of different species or protoplast fusion including hybridoma cells and plant cell hybrid acquisition; 8.1.4. pašklonēšan, which led to the goal that organisms are not dangerous to humans, animals or plants and may not cause the disease, isolation of nucleic acid of such organisms cells that follow or not follow all relevant nucleic acid, or its synthetic equivalent, enzimātisk 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. You can use the Pašklonēšan recombinant vector for which the use of the safe in a given cell is a sufficiently long experience; 8.2. the genetically modified organisms limited uses involving only types of genetically modified organisms which meet the provisions of annex 1 of the criteria that determine genetically modified organisms are harmless to human health and the environment; 8.3. the genetically modified organisms by rail, road, inland waterway, sea or air, in so far as it does not apply to information security measures and any possible accident prevention. The accident is any accident involving a significant and unintended escape of genetically modified organisms in the course of their contained use which could present an immediate or delayed hazard to human health or the environment for some time; 8.4. the cures, and veterinārfarmaceitisk of the veterinary medicinal product on the market to distribute products, except for the risk assessment according to the requirements of this regulation.
9. in order to carry out the activities with genetically modified organisms, natural or legal person (hereinafter applicant) shall submit an application for genetically modified organisms and the new food monitoring Council (hereinafter Council) secretariat of the Latvian food centre. Application-information required in a submission to the Secretariat of the Council. 10. In the application, the applicant claims: 10.1. information about risk assessment in accordance with the provisions of chapter II and 2, 3, and 4. the requirements referred to in the annex. Risk assessment is the direct or indirect, immediate or delayed effects on human health and the environment, which can lead to genetically modified organisms in contained use, deliberate release into the environment or distribution market; 10.2. the security measures used genetically modified organisms for limited use, referred to in annex 5 of these regulations; 10.3. information in accordance with the provisions of annex 6 and 7 of the genetically modified organisms deliberate release into the environment and market penetration; 10.4. detailed information on each of the genetically modified organisms for the use or dissemination of case, if required by these rules; 10.5. a summary of the information presented under this provision in annex 8 requirements, if genetically modified organisms for knowingly distribute or disseminate market environment; 10.6. the information which is considered restricted access information, stating that they are going into the disclosure might cause a loss to the manufacturer's competitiveness. The Council, in consultation with the applicants, agree on specific information that can be allocated to restricted availability status. Restricted availability status is not granted, the following information: 10.6.1. the applicant's name, address (legal person – name and address); 10.6.2. Description of the genetically modified organism that allows it to be identified; 10.6.3. genetically modified organisms in the distribution, location, and purpose of the intended use or genetically modified organisms in contained use of a place of safety class and containment; 10.6.4. monitoring the genetically modified organism and emergency plans; 10.6.5. risk assessment opinion.
11. If the applicant withdraws the application, the Latvian food centre and the Council shall ensure that the information is not disclosed. 12. The Latvian food centre within 90 days of receipt of the application, shall issue to the applicant a written response if these rules are not specified otherwise. If the Council has requested the applicant to submit additional information or an additional tutorials, additional information or consultation required time is not included in this term. Survey of the public and the public consultation on the review of the application may be extended by not more than 30 days. 13. Prohibited without the authorization of limited use genetically modified organisms under the third and the fourth class of security, deliberately spread in the environment of genetically modified organisms and genetically modified organisms to spread or components containing products on the market, if the Member States of the European Union they have so far been distributed in the market. 14. Authorisations shall be issued by the Council: 14.1. The Latvian food centre – genetically modified organisms for contained use; 14.2. the national natural protection administration – genetically modified organisms deliberate release into the environment; 14.3. The Latvian food centre – the Member States of the European Union does not register the distribution of genetically modified organisms on the market.
15. The Latvian food centre, following a recommendation from the Council for the exchange of information with the applicant, the Member States of the European Union and Commission of the European Union.
16. If genetically modified organisms or their components use or distribution is changed so that genetically modified organisms may adversely affect human health or the environment, or the consideration of the application of the new information obtained in the course of such adverse effects, the applicant: 16.1. take additional measures to protect human health and the environment; 16.2. immediately (during the week) will inform the Council of such organisms or their components change; 16.3. the Council shall prepare and submit a new application.
17. If the Board receives information about distributable on the market of genetically modified organisms create hazards to human health or the environment: 17.1. without the prior written authorisation of the Latvian food centre will immediately forward this information to the Commission, the European Union and the rest of the European Union, the competent authorities of the Member States. The Council may discuss the issue with the European Union, the competent authorities of the Member States, 75 days prior written authorisation; 17.2. the written authorisation of the Latvian food centre within 60 days of the receipt of new information sent to the Commission by the Council on the change of the conditions of authorisation, if it is necessary.
18. the costs associated with these rules in the document referred to in paragraph 9 shall be borne by the applicant for inspection, and the payment for these services receive the Latvian food centre;
18.1. for genetically modified organisms in contained use under the third and fourth class – 1051.30 ls (without VAT); 18.2. on the deliberate release into the environment of genetically modified organisms – 1469.40 ls (without VAT); 18.3. the genetically modified organisms on the market – 2425.90 ls (without VAT); 18.4. about this rule referred to in paragraph 12 of the Council requested additional information expertise – 298.64 lats (VAT Excl.).
19. the genetically modified organisms for contained use, deliberate release into the environment and the monitoring of the distribution market, coordinate and consumers about genetically modified organisms shall inform the Council of the movement. 20. The Latvian food centre: 20.1. creating a database, including the following: 20.1.1. genetically modified organisms deliberate release sites in accordance with the provisions of chapter IV; 20.1.2. genetically modified organisms growing on the site in accordance with the provisions of chapter V; 20.2. the information published in the newspaper "journal" of Latvia permits for genetically modified organisms limited use, deliberate release into the environment and market penetration, as well as the Member States of the European Union market genetically modified organisms or their products. Information to the person who submitted the application for authorisation of activities with genetically modified organisms, genetically modified organisms, authorised use of the name and date of the authorization granted. Information on Latvia accepted genetically modified organisms shall be published two weeks after the issue of the permit. This information is also placed in the Latvian food centre's website on the internet.
II. Risk assessment, making transactions with the modified organisms 21. Before the submission of the application to evaluate genetically modified organism potential risk to ecosystems and to take into account the following risk of increasing basic: 21.1. pathogenicity in humans, animals or plants, including allergenic or toxic effects; 21.2. the ability to interfere with the operation of preventive or curative nature; 21.3. the effects on the population dynamics of genotype environment, which will be distributed for genetically modified organisms; 21.4. exposure to the ģeoķīmisk process; 21.5. the genetically modified organisms for unlimited distribution; 21.6. the consequences if genetic material unlimited moves to other organisms; 21.7. the genetically modified organisms for phenotypic and genetic instability.
22. the main stages of the risk assessment considers the following: 22.1. to determine the characteristics of the organism, which can cause negative effects; 22.2. the possible impact the alleged negative effects, if any, evaluation of impact; 22.3. the identified potential adverse effect likelihood of the assessment; 22.4. that the risk assessment is created by each identified genetically modified organism in a sign; 22.5. application of management strategies for risks that may arise, the genetically modified organisms to the environment or distribution market; 22.6. the genetically modified organisms in the determination of the overall risk.
23. In assessing the risk and giving its assessment of the genetically modified organisms for limited use, consider these rules referred to in annex 4. 24. The assessment of risk and providing its assessment of genetically modified organisms deliberate release into the environment and market penetration, take into account the provisions of annex 2 of the risk assessment referred to in the principles and the rules referred to in annex 3 instructions for carrying out the risk assessment.
III. the genetically modified organisms for contained use 25. Each genetically modified organisms used in case the applicant determines the degree of restriction on the basis of the risk assessment carried out in accordance with the provisions of chapter II, as well as the Cabinet of Ministers regulations on labour protection requirements when dealing with biological substances. Restrictions of the modified organism grades meet the four safety class: 25.1. first security class correspond to activities that are either not pose, or the danger that the rise is negligible. They are activities that meet the first limit, in order to protect human health and the environment; the second security 25.2. class corresponds to activities that pose a slight risk. They are activities that meet the second limit, in order to protect human health and the environment; 25.3. third security class correspond to activities that pose a moderate risk. They are the activities that correspond to a third-degree limit, in order to protect human health and the environment; 15.8. the fourth security class correspond to activities that pose a high risk. They are activities that comply with the restrictions of the fourth degree, in order to protect human health and the environment. 26. Expected in the genetically modified organisms for contained use security class applicant indicates in the application. 27. If there is reasonable doubt as to which genetically modified organisms in contained use security class is applicable for the use intended, subject to the higher limit, if the Council these rules referred to in point 14 of the recommendation, has indicated that can be applied to the lower limit.
28. the genetically modified organisms for the first class of security attributed the limited use of genetically modified organisms, which are characterized as follows: 28.1. is resolved or reduced non-genetically modified organism or cell in the modified organism in adverse impacts on the environment; and from the new vector 28.2. entered the nature of genetic material is one that arises due to the characteristics of the genetically modified organism that could cause disease to humans, animals or plants or adversely affect the environment. 29. periodically examine the Application provides appropriate control and security measures in accordance with annex 5 of these rules. : 29.1. making first class limited use of security, not less frequently than once every three years; 29.2. the second class of limited use, not exceeding two years; 29.3. the third and fourth classes of limited use, not less than annually; 29.4. the control and security measures are to be evaluated immediately if: 29.4.1. they no longer suit or genetically modified organisms in contained use is no longer meets the prescribed safety class; 29.4.2. There is reason to believe that the control and security measures can no longer meet the latest scientific or technical knowledge.
30. The applicant is responsible for the following: 30.1. prior to the application to determine the possible risks and the appropriate degree of limitation in accordance with the provisions of the second paragraph of Chapter 3, annex 2 of the first and the second chapter, annex 4 and the Cabinet of Ministers regulations on labour protection requirements when dealing with biological substances; 30.2. indicate the General agenda and control and security measures in accordance with annex 5 of these rules and genetically modified organisms in contained use safety class to guarantee safety and genetically modified organisms to the lowest feasible level of pollution at the workplace and in the environment; 30.3. two weeks to inform the Council, if new information is obtained, the control mode, or significantly modified genetically modified organisms in contained use conditions; 18.9. to draw up emergency plans in cases where it is found in the genetically modified organisms for limited use policy violations. The plan must be submitted to the Council and the institutions, whose activities can affect the emergency; 5. to submit a new application, if genetically modified organisms for a limited class of security; 30.6. the keep opinion risk assessment documents and produce, on request, to the competent authority; 19.1. If the premises of genetically modified organisms for use in limited use for the first time, the application shall indicate the following information: the name of the user and 30.7.1 for surveillance and security measures for persons (names); 30.7.2. information on training and qualifications of the persons responsible for supervision and safety measures; 30.7.3. space address and general description; 30.7.4. Description of the work to be carried out; 30.7.5. expected for genetically modified organisms in contained use security class; 30.7.6. risk assessment opinion according to the requirements of these provisions and information on waste and waste management.
31. The applicant is allowed to initiate activities with genetically modified organisms in premises of the first class of security restricted for use by the application to the Council in accordance with the provisions of section 19.1. on assuming full responsibility for possible damage to human and animal health, biodiversity and the environment. The future of the first class of safety of genetically modified organisms limited the use of these facilities may be made without additional notification, keeping risk assessment documents for each of the opinion of genetically modified organisms. 32. The applicant may use the space activities with genetically modified organisms under the second safety class limited use of the lodging of an application to the Council in accordance with the provisions of section 19.1. such information: 32.1. the date of submission of the application; 32.2. the surveillance and security measures, the person in charge (name, surname) and information on the training and qualifications of those persons; 32.3. the use of the recipient, the donor or parental organisms and the vector system; 32.4. the modification to the source of the genetic material and the intended functions; 32.5. the genetically modified organisms for identity and characteristics; 32.6. the genetically modified organisms for the purpose of the contained use including the expected results; 32.7. the intended crops; 20.4. the control and protective equipment to be used, including information about waste collection, processing, and disposal of final form; 32.9. risk assessment opinion according to the requirements of this regulation; 32.10. the required information to evaluate any accidents and prevention plan.
33. If other genetically modified organisms safety class for use in the limited areas where genetically modified organisms second or higher security class contained use, activities with genetically modified organisms may be to start 45 days after submission of the application in accordance with the provisions of paragraph 32, or earlier if the Council so agrees. 34. activities with genetically modified organisms under the second safety class limited to use by the applicant may start immediately after the application for premises in which there has been a second or higher class of contained use of safety in accordance with previously submitted applications and corresponding requirements are provided. The applicant may request a decision from the Council for formal approval. The decision shall be taken within 45 days of receipt of the application. 35. The applicant is allowed to use the space activities with genetically modified organisms under the third and fourth classes of security restricted for use unless written authorisation has been obtained, the lodging of an application to the Council in accordance with the provisions of section 19.1. such information: 21.8. the date of submission of the application; 35.2. about surveillance and security measures, the person in charge (name, surname) and information relating to training and qualifications; 35.3. the use of the recipient or parental organisms; 35.4. the recipient used the vector system (if necessary); 22.1. the genetic material involved in the modification to the source and intended functions; 35.6. the genetically modified organisms for identity and characteristics; 22.2. cultural use; 22.2. the control and protective equipment to be used, including information about waste collection, processing, and disposal of final form;
22.3. the genetically modified organisms for the purpose of the contained use including the expected results; 35.10. laboratory equipment and installations; 35.11. information about accident prevention and emergency response plans, if such an accident can occur: any specific threat 35.11.1. associated with the location of the machine; 35.11.2. applicable precautions such as safety equipment, alarm systems and containment methods; 35.11.3. effectiveness of control measures in constant inspection procedures and plans; 35.11.4. Description of the information available to employees; 35.11.5. the information required to assess all the Council, emergency response plans, if required; 35.12. risk assessment opinion according to the requirements of this regulation.
36. The written authorisation of genetically modified organisms in accordance with the limited use of third and fourth class of security after a recommendation from the Council, shall be issued by the Latvian food centre: 36.1. not later than 45 days after the receipt of the application for the new premises, which earlier announced in connection with the third or higher class safety of genetically modified organisms and the use of a limited if all necessary requirements for the permit are met; 36.2. not later than 90 days after receipt of a notification under paragraph 12 of these rules, in other cases.
37. the genetically modified organisms for contained use, the applicant provides the following safety and hygiene: 37.1. ensure jobs and effects of genetically modified organisms to the environment would be a permissible level of risk; 37.2. with special devices to physically demarcate the genetically modified organisms from exposure to the staff using the staff regulations established for the protection of appropriate clothing and personal protective equipment; 37.3. inspect and maintain the agenda of control means and equipment; 37.4. controls the viable organisms outside the area to physically demarcate the modified organisms; 37.5. ensure that staff would be trained to work with genetically modified organisms; 23.4. develop specific safety rules that staff must follow when working with genetically modified organisms; 37.7. deploy signs indicating on biological hazards; 23.5. the staff shall be disinfected and shower room; 23.5. accurately accounted for and recorded in the operations performed with the modified organisms; 37.10. prohibit the staff work to eat, drink, smoke, use makeup or keep food; 37.11. prohibit the staff working with the pipette, apply mouth; 37.12. develop written instructions that must be followed when performing certain dangerous work operations with genetically modified organisms; 37.13. provides rooms with effective disinfectants and disinfection procedure specific to local pollution, genetically modified organisms, 37.14. take measures to secure and isolate the contaminated laboratory equipment and materials.
IV. Deliberate release of genetically modified organisms into the environment 38. Permission to genetically modified organisms into the environment, the applicant in this application include the following: 38.1. detailed information set out in accordance with the provisions of annex 6; 38.2. the genetically modified organisms for use in risk assessment of possible according to the requirements in these rules; 38.3. the opinion of the risk assessments in accordance with the provisions of annex 2, chapter IV, including the bibliographic reference of the ces and the indication of the methods used; 23.9. the information that the applicant considers relevant, or the information previously submitted by other notifiers, provided they have given their written consent.
39. the Council may apply a differentiated procedure for the authorisation of genetically modified organisms into the environment by establishing simplified procedures for genetically modified organisms deliberate release into the environment. It shall apply, if genetically modified organisms in sufficient experience has been obtained and the genetically modified organisms shall meet the following criteria: 24.3. is a well known non-genetically modified organism (recipient) and nationality grouping biology (such as reproduction and pollination, ability to cross way with related species); 24.4. the obtained knowledge of human health and environmental safety, distributing non-genetically modified organisms (the recipient); 39.3. the genetically modified organisms in the experimental release conditions, allergenicity pathogenicity and toxicity is not able to inflict more damage to human health or the environment than the corresponding non-modified organism. Genetically modified organisms could enter the environment, spread to other ecosystems and transfer genetic material to other organisms, there is no reason to anticipate any adverse effects on human health and the environment; 39.4. the foreseeable distribution use the genetically modified organism distribution methods that are analogous to other forms of distribution, the use of which has already been authorised, and the results obtained do not indicate that the estimated damage to human health and the environment would be impossible; 24.5. is available for complete information on all the vektorsistēm and the genetic structure of the insert, which can be used to genetically modified organisms and their offspring, as well as for the identification of the known extent of the deletion, if the genetic modification is associated with a deletion of genetic material.
40. Should the Council decide to apply this provision in paragraph 39 that the simplified procedure, the Latvian food centre within the Commission of the European Union submitted a reasoned proposal for the application of differentiated procedures to such types of genetically modified organisms.
41. If the same genetically modified organism, or the same combination of genetically modified organisms into the environment of the distribution takes place in different locations, but in a limited time and with the same purpose, the applicant may submit a single application.
42. The applicant may start proliferation environment only if you have received written authorization by the Council by the State environmental protection administration. The distribution of the applicant under any conditions specified in the permit. 43. in accordance with the authorisation for genetically modified organisms deliberate release into the environment of the applicant to provide the Council with information on the results of releases, if necessary, with particular reference to any type of product for which the applicant intends to report later. This information is presented according to this provision, 7. the requirements set out in the annex.
V. genetically modified organisms and products containing 44. Applicant on the market, for the first time in a Member State of the European Union the dissemination of genetically modified organisms on the market, the application shall state: 44.1 6 and these regulations. 9. the information referred to in the annex, and, if necessary, a justification Annex 9 paragraph 2 without application; 44.2. genetically modified organism intended use may risk assessment according to the requirements of this regulation and recognized mu under this provision 2. Chapter IV of the annex; 44.3. the conditions for distribution of the products on the market, including specific conditions of use and storage; 27.6. the planned period of validity of the permit; 27.7. the monitoring plan in accordance with Chapter VI, including the proposal on the implementation of the monitoring plan and taking into account this provision in annex 10 instructions: 27.7. proposals for labelling and packaging according to the rules referred to in annex 4; 44.7. a summary of the information submitted in accordance with the rules referred to in annex 8 requirements; 27.8. information on Latvia or in the Member States of the European Union previously logged analogues genetically modified organisms, where the relevant application, the applicants have provided written consent.
45. If genetically modified organisms as or is intended to be used for other purposes than indicated in previous submissions, submit a new application. 46. The Latvian food centre under the management of regulatory laws and adopt the application, checks whether the application complies with this provision in paragraph 44 of the requirements and, if necessary, ask the applicant for additional information. 47. If the application complies with this provision of the 44, Latvian food centre sends these rules 44.7. the summary referred to in the European Union, the Commission and the other Member States of the European Union institutions on the relevant competence. 48. the Council on application within 90 days of the inspection drawn up by the Latvian Food Assessment Centre sent: 29.9. applicant. If the applicant withdraws the application, then the cancellation does not limit to submit this application in another Member State of the European Union before the competent authority; 48.2. European Union Commission: 48.2.1. all of the information on which the assessment is based, proposes to issue the permit if the genetically modified organism into the market; 48.2.2. all of the information on which the assessment is based, if the propose withhold authorization for genetically modified organism concerned into the market, sent no sooner than 15 days after the dispatch of the assessment and to the applicant not later than 105 days after receipt of the application.
49. These provisions 48. assessment of the Council referred to in paragraph 1 shall include the following information: 49.1. it table of contents identification of uztvērējorganism relating to the assessment of genetically modified organism. All the known hazard identification that human health and the environment of non-genetically modified uztvērējorganism in the distribution environment; 30.6. the genetically modified organisms in genetic modification; 30.6. the assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and the environment; 49. all the risks resulting from the identification of new relevant to human health and the environment which may lead to the spread of genetically modified organisms in comparison with the non-genetically modified organisms, and based on a risk assessment, which shall be made in accordance with the provisions of chapter II and annex 2; 30.8. a detailed opinion on whether and under what conditions the genetically modified organism or products thereof on the market or distributed the genetically modified organism does not distribute, market or on specific risk assessment questions asked of other competent authorities and the Commission. Opinion attributed to the genetically modified organisms for the proposed use, risk management, and the proposed monitoring plan. If, in accordance with the opinion of the genetically modified organisms are not distributed in the market, the Council gives its opinion.
50. If the Council has decided that the product can be distributed on the market and within a period of 60 days following the assessment referred to in paragraph 48 of the ship from any Member State of the European Union is not received or received opposition motivated issues solved 105 days, the Latvian food centre shall prepare a written authorization for distribution on the market, shall transmit it to the notifier within 30 days and inform the other Member States of the European Union. 51. the authorisation of genetically modified organisms or their products on the market shall be issued for a period of up to ten years. 52. the written permission stating: 52.1. the scope of the permission, including market distributed identity products containing or consisting of ones, and their unique identifier; 52.2. the period of validity of the authorisation; 52.3. the conditions for distributing the product on the market, including any specific condition of use, handling and packaging of the genetically modified organisms or consist of, and of particular ecosystems/environments and/or geographical areas protection conditions; 52.4. controls the handover to the competent authorities to provide for the privacy requirements; requirements for labelling according to 52.5. in annex 8 of these rules; 52.6. monitoring requirements in accordance with Chapter VI of these provisions and having regard to annex 11 of the instructions, including: 52.6.1. the monitoring plan due dates; 52.6.2. steps if necessary, genetically modified organism product vendors or users; 52.6.3. the cultivation of genetically modified organisms in the case of the specific information that is considered necessary in the place of production.
53. in order to restore the permit the applicant for at least nine months before the expiry date of the authorisation shall be submitted to the Council (unless the Council has examined the submission previously issued) application along with a copy of the authorization granted above, including: 53.1. the monitoring data obtained in the previous distribution period in accordance with the monitoring plan submitted pursuant to the provisions of Chapter VI; 53.2. any other information that is accessible and relevant to a product's potential harm to human health or the environment; 53.3. the amendment of the original permit or conditions, if any, topping the intended as well as conditions for further monitoring and authorisation period.
54. The Latvian food centre under the management of the regulatory laws and accept the renewal of authorisations, checks whether the application complies with the provisions of paragraph 53 of these requirements and, if necessary, ask the applicant for additional information. 55. If the application complies with the provisions of paragraph 53, the Latvian food centre shall immediately send to the applicant and the Commission of the European Union of a copy of the application and the assessment, indicating one of the following: 55.1. the genetically modified organisms may continue to spread in the market, and point to certain conditions; 55.2. the distribution of genetically modified organism is discontinuing.
56. If the Council has decided that the product may continue to spread in the market, and within 60 days after the provision of assessment referred to in paragraph 55 of the ship not from one Member State of the European Union or of the European Union Commission not received motivated objections or issues resolved received 75 days, the Latvian food centre shall prepare a written permission for further distribution on the market, shall transmit it to the notifier and, within 30 days, inform the Commission of the European Union and the other Member States of the European Union.
57. the duration of authorisation is 10 years. If you have a valid need, may be limited or extended. Justification the Council evaluated. 58. the distribution of the market does not believe the genetically modified organism, including the culture collection, transfer the activities which follow appropriate stringent containment measures are used to limit their contact with the general population and the environment and ensure safety in accordance with the provisions of chapter III.
Vi. Trade in genetically modified organisms distributed monitoring 59. Monitoring supports the applicant after the market to distribute products containing or consisting of them. Reports on monitoring in accordance with the conditions laid down in the authorisation, shall submit to the Council, the Commission and the European Union, the European Union Member States competent authorities. 60. the Council, on the basis of reports on monitoring what happens according to the conditions in the permit issued, can approve the monitoring plan after the first monitoring period. 61. By drawing up the monitoring plan, taking into account this provision in annex 10. 62. the purpose of the Monitoring plan: 62.1. confirm that all risk assessment findings relating to the genetically modified organism or its usage potential adverse effects or impacts, are correct; 62.2. identify the genetically modified organism or its use in adverse effects on human health or the environment and which are not provided for in the risk assessment.
63. the Monitoring plan for the preparation of the guiding principles: 39.2. monitoring shall be carried out after receiving the authorization of genetically modified organisms for distribution market; 39.3. the monitoring data obtained in the interpreted, taking into account the different environmental conditions and activities. If changes in the environment are observed, further assessment is needed to determine: 63.2.1., or genetically modified organisms or their use; 63.2.2. or they have other environmental factors, which are not genetically modified organisms on the market; 63.3. developing monitoring plans, which need to spread the market products containing genetically modified organisms or consisting, uses the experience and data obtained in genetically modified organisms through the monitoring of experimental releases of.
64. The guidelines for the design of the monitoring plan: 64.1. in each case take into account the details of risk assessment opinions; 64.2. takes into account all specific genetic modified organism intended use scale and performance, and the conditions in the environment in which the modified organism will be distributed; 64.3. unanticipated adverse effects of general monitoring and, if necessary, case-specific monitoring focusing on disadvantaged effects identified in the risk assessment opinion: 64.3.1. in view of the fact that each case long enough implemented specific monitoring to detect immediate and direct as well as, where appropriate, delayed and indirect exposure to identified risk assessment opinion; 64.3.2. Noting that the implementation of the monitoring, as appropriate, the use of already established whereas monitoring, such as agricultural cultivars, plant protection, or veterinary and medical products, monitoring, explains how the permissions available to the beneficiary with the relevant information obtained from monitoring standartpasākumo; 64.4. plans to systematically take the proliferation of genetically modified organisms in the ecosystem observation and interpretation of observations in relation to the safety, for human health or the environment; 64.5. determines that the applicant or the Executive – users – various tasks laid down in the monitoring plan requires and who is responsible for the design of the monitoring plan and proper implementation, as well as ensure that the consent holder and the competent authority will be informed of all the observed poorer effects on human health and the environment. Point times and intervals for reporting monitoring results; 64.6. provides mechanisms for all the observed adverse effects identification and approval and the opportunity given to the holder or the competent authority, if necessary, to take measures to protect human health and the environment. 65. Reports on monitoring carried out by the Latvian food centre placed the site on the internet.
VII. Monitoring and supervision of compliance with these provisions 66. State supervision and control within the limits of its competence provides food and veterinary service, the State environment inspectorate, national plant protection services or the national labour inspectorate, if necessary, through competent testing laboratory for analysis.
67. in the event of a threat to human life or health, the Chief Inspector of the controlling authorities are entitled to impose restrictions or prohibitions on the dissemination of GMOs, notifying the Council and community.
VIII. security of information 68. Latvian food centre provides European Union Commission: 68.1. every three years the European Union sent the Commission a report on the measures taken in implementation of those rules. This report shall include a brief report on the experience acquired in the work with genetically modified organisms in contained use and modified organisms or their products on the market, in accordance with these rules. For the first time it reported in June 2007; 68.2. at the end of each year, the European Union sent the Commission a summary report on genetically modified organisms used in categories 3 and 4 processes, which allowed this year, including this description of the process used, the objectives and the related hazards; 68.3. it shall immediately inform the Commission and the other Member States of the European Union on the decisions which it adopts in accordance with the provisions of paragraph 67, if food and veterinary inspector has banned a genetically modified organism or its products on the market. Information on whether and how it would be amenable to distribution, the conditions of authorization or terminated, and motivates the decision, submitting the findings of the risk assessment, which, if necessary, provide new or additional information on which the decision is based; 68.4. sent the European Commission a summary of each application within 30 days after the receipt of each application in accordance with these provisions on the deliberate release into the environment of genetically modified organisms; 68.5. If the Council received from the Commission of the European Union for evaluation of one of the Member States of the European Union summary of the application of genetically modified organisms deliberate release into the environment, the Council within 30 days of the Commission of the European Union or Member State may submit directly to the Council. The Council may ask the Member States of the European Union concerned to the competent authority to send a copy of the complete application, if it is necessary to evaluate the application; 68.6. comments, or present reasoned objections within a period of 60 days, if received in other Member States of the European Union ratings for new genetically modified organisms in the distribution market; 68.7. the decisions adopted in the distribution of genetically modified organisms into the environment, motivating the rejection notice; 68.8. for genetically modified organisms, which are received in accordance with the provisions of paragraph 43; 42.8. once a year sends it in Latvia distributing genetically modified organism list, distributed or refused, taking into account the differentiated evaluation of genetically modified organisms.
69. If an accident happened to genetically modified organisms in the border area, the Latvian food centre as soon as possible after coordination with the Foreign Ministry to inform the authorities in the countries concerned on the proposed implementation of emergency plans. 70. If genetically modified organisms in contained use, distribution, environment or market affect the level of environmental pollution in another Member State of the European Union, Latvian food centre after coordination with the Foreign Ministry to inform the Commission of the European Union for each accident covered by these regulations, giving details of the circumstances of the accident, the genetically modified organism identity and quantities of the emergency measures taken and their effectiveness, as well as the analysis of the accident to include recommendations to limit the effects of the accident and avoid similar accidents in the future.
IX. concluding issues 71. Genetically modified organisms contain genes that encode resistance to be used in human or veterinary antibiotics, be distributed on the market until 31 December 2004, if such distribution is identified in the Member States of the European Union, but the proliferation of genetically modified organisms in the environment is forbidden. 72. Be declared unenforceable in the Cabinet of 19 September 2000, the Regulation No 323 "genetically modified organisms and the use of the distribution order" (Latvian journal, 2000, 321./333.nr.; 2002, nr. 18).
Informative reference to the European The directives included in the provisions of the EU law 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 on 23 April 1990 directive 90/219/EEC on genetically modified micro-organisms.
Prime Minister i. Emsis Health Minister r. Muciņš annex 1: Cabinet of Ministers of 20 April 2004 the Regulation No 333 of the genetically modified micro-organism in the safety to human health and the environment criteria 1. Genetically modified micro-organisms are harmless for human health and the environment general criteria: 1.1. strain verification/authentication is defined. Determining the precise identity of the strain. The modifications have been known and tested; 1.2. the body for safety evidence is documented; 1.3. genetic stability. If the instability may adversely affect the security, then demonstrate stability.
2. Genetically modified micro-organisms are harmless for human health and the environment special criteria: 2.1. genetically modified micro-organism is not a pathology (applies to both toxicological and allergenicity), it does not cause disease and did not cause any injury to human, plant or animal health. Genetically modified micro-organism is: 2.1.1. toxic. Genetically modified micro-organism genetic modification must not increase the toxic effects, and it may not be toxic characteristics; 2.1.2. alergēnisk. Genetically modified micro-organism genetic modification may not be increased allergenicity as well it may not be the alergēnisk properties that are comparable to the allergenicity of the micro-organism to be determined by the laws and regulations on labor protection requirements when dealing with biological substances; 2.2. genetically modified micro-organism contains no harmful adventitious agents such as other assets or latent microorganisms in addition or genetically modified micro-organism itself, which could be harmful to human health and the environment; 2.3. the genetically modified material is not harmful to the transmission case, nor even move or is portable more often than the other recipient or parental micro-organism of genes; 2.4. environmental security a significant and unintended release. Genetically modified micro-organism immediately or after a period of time, harmful effects on the environment, not if the crashes associated with significant and unexpected genetically modified material into the environment.
Health Minister r. Muciņš annex 2 Cabinet of 20 April 2004 the Regulation No 333 of Risk assessment principles i. General risk assessment principles 1. risk assessment, the following general precautionary principle: 1. identify the characteristics of the modified organism, which can cause undesirable effects in certain applications, compared with properties that have non-modified organism from which the relevant conditions is obtained from the modified organism; 1.2. the risk assessment shall be based on scientific knowledge about the characteristics of the modified organism; 1.3. the risk assessment shall be carried out for each modified organisms and its propagation; 1.4. the risk assessment shall be carried out again if the modified organism effects on human health or the environment as new information becomes available.
Ii. Methodology. Characterization of the modified organism to the conditions for distribution and 2. the Risk assessment shall take account of the scientific knowledge on: 2.1.-genetic modification of organisms of the recipient and the donor; 2.2. for genetic modification of/s/j and modified organisms; 2.3. the expected distribution or usage and its scale; 2.4. the potential of ecosystems; 2.5. this annex 2.1., 2.2., 2.3 and 2.4 in the interaction between these.
3. Risk assessment information used in the analysis of similar organisms and organisms with similar traits and their interaction with similar environments. Iii. Methodology. Risk assessment stages 4. Risk analysis the applicant prepare a modified organism risk assessment, which the Council, in cooperation with the applicant evaluated in the following order: 4.1 adverse effect radītspējīg conditions: 4.1.1 identification identifies characteristics of the modified organism, which can cause adverse effects on human health or the environment. 4.1.2 identify the modified organism to adverse effects on human health or the environment, including: 4.1.2.1. various human disorders , allergic or toxic effects; 4.1.2.2. various animal and plant diseases, allergic or toxic effects on animals; 4.1.2.3. effects on the population dynamics of species and ecosystems, as well as on each of the genetic diversity of a population; 4.1.2.4. altered susceptibility to pathogens facilitating the dissemination of infectious diseases and ways; 4.1.2.5. interference in medical/veterinary prevention or care, plant protection; impact 4.1.2.6. biogeochemical cycles, particularly carbon and nitrogen circulation; 4.1.3. adverse effects may be direct or indirect, and implemented in the following way: 4.1.3.1. modified organisms spreading; 4.1.3.2 it. jaunveidot transfer genetic material to other organisms, or the same organism whether genetically modified or not; 4.1.3.3 citizens of phenotypic and genetic with instability; 4.1.3.4. interaction with other organisms; 4.1.3.5. with the changes in the management of agricultural practices; 4.2. each of the adverse effects likely effect assessment, assuming that this impact the implementation. The effect size may affect the environment in which distributed modified organisms, as well as their distribution; 4.3. the occurrence of each identified potential adverse effect likelihood of the rating. Adverse effects on the likelihood of significant impact on the environment in which the modified organisms will be distributed, and organisms; 4.4. each of the identified characteristics of the modified organism risk analysis. Risk posed by each identified characteristic of the modified organism to human health or the environment, assessed, as far as possible, the adverse effects of the combination of the likelihood of the consequences of its size; 4.5. the existence of a risk management strategy, the modified organism resulting from the deliberate release into the environment or the market. The risk analysis shall determine the best risk management; 4.6. the modified organism produced overall risk assessment which takes into account all possible manifestations of risk components and proposed risk management strategy.
Iv. Methodology. Opinion on the distribution of modified organisms in nature or market 5. to facilitate the drawing of conclusions about the potential environmental impact of the modified organisms spreading in nature or in the market, and, on the basis of a risk assessment carried out in accordance with the principles and methodology set out in annex II and III of this title, if necessary, the applications shall include the information contained in this annex in paragraphs 6 and 7. 6. In its opinion on the modified organisms other than higher plants, include the following information: 6.1 the probability that the modified organism to become persistent and invasive in places of distribution for the distribution conditions; 6.2. all the favourable or unfavourable selective in which inherited characteristics of the modified organism that is received, and the probability that it will materialise under the conditions of the proposed release; 6.3. potential for gene transfer to other species of GMOs under the conditions of the proposed release and all selective unfavorable or adverse which inherited characteristics to those species; 6.4. possible immediate or delayed environmental impact resulting from the modified organism and target organisms (if applicable) the direct or indirect interaction; 6.5. the possible immediate or delayed environmental impact resulting from the modified organisms and non-target organisms in the direct and indirect interactions, also impact on competitors, the victim, vektororganism, symbionts, predators, parasites and pathogens in quantity; 6.6. potential effects of immediate or delayed, on human health, cause potential direct and indirect interactions of the modified organism with the people you work with modified organisms, coming into contact with or in the vicinity of; 6.7. the possible immediate or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the modified organism and any products derived from it, if it is intended for animal feed; 6. possible immediate or delayed effects on biogeochemical processes resulting from potential direct and indirect modified organisms, and the interaction of target and non-target organisms in the modified organism distribution area; 6.9. the possible immediate or delayed, direct and indirect impacts on the environment caused by the specific management practices the modified organism if they differ from those used for non-GMOs.
7. in the Opinion of genetically modified higher plants (higher plants) include the following: 7.1 the probability that higher plants become persistentāk than the recipient or parental plants in agricultural areas or more invasive in natural areas of distribution; 7.2. all the favourable or unfavourable to the selective in which inherited characteristics received by higher plants; 7.3. potential for gene transfer to the same or other sexually compatible plant species under conditions of planting higher plants and all selektīvo favourable or unfavourable factors, those plant species.; 7.4. possible immediate or delayed environmental impact resulting from higher plants and target organisms, such as predators, parasitoids, and pathogens (if applicable) the direct and indirect interactions; 7.5. the possible immediate or delayed environmental impact resulting from higher plants from direct and indirect interactions with non-target organisms, also taking into account organisms which interact with target organisms, as well as the impact on competitors, herbivores, symbionts, if any amount, parasitoids, and pathogens in the population; 7.6. possible immediate or delayed effects on human health resulting from potential direct and indirect in higher plants and the interaction of the persons who work with higher plants, coming into contact with or in the vicinity of; 7.7. possible immediate or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the modified organism and any products derived from it, if it is intended for animal feed; 7.8. possible immediate or delayed effects on biogeochemical processes resulting from potential direct and indirect modified organism and target and non-target organisms in the interaction of modified organisms area; 7.9. the possible immediate or delayed, direct and indirect environmental impacts of the specific cultivation of the higher plants, management and harvesting techniques, if they differ from those used for non-genetically modified higher plants cultivation, management and harvesting.
Health Minister r. Muciņš annex 3 of the Cabinet of Ministers of 20 April 2004 the Regulation No 333 methodical guidance for risk assessment risk assessment objectives, general principles and methodology 1. Assessment of risk and providing its assessment of genetically modified organisms (including genetically modified micro-organisms, plants and animals) the deliberate release into the environment and market penetration, in addition to annex 2 in relation to the objectives of the risk assessment followed that: 1.1 the objective of risk assessment is a case by case basis, to identify and evaluate potential harmful direct and indirect, immediate or delayed the genetically modified organisms effects on human health and the environment, which can lead to genetically modified organisms deliberate release into the environment or distribution market. Assess the risks to determine the need for risk management and, if required, use the most appropriate methods; 1.2. distribution of the market often involves the deliberate release into the environment (for example, the distribution of agricultural products containing or consisting of them and which are intended only for food, animal feed or processing). Also in this case, the risk assessment shall be included in the application process. Risk assessment submitted for the deliberate release into the environment may differ from that presented on the market because the different is the existing data, timing and area; 1.3. risk assessment is the basis for determining the need for risk management and, if necessary, the most appropriate methods to be used, as well as the need for targeted monitoring (see chapter II); 1.4. the overall assessment of the case applies to certain genetically modified organisms (judged each genetically modified organism) and the environment in which genetically modified organisms to distribute (for example, where each area assessed and each region); 1.5. the genetically modified organisms to the different categories of effects on human health or the environment may include: 1.5.1. direct impact – the primary effects on human health or the environment caused by genetically modified organisms and that there is not a causal chain of events (for example, Bt toxin direct effects on target organisms, or the pathogenic micro-organisms genetically modified for effects on human health); 1.5.2. the indirect effects-effects on human health or the environment occurring through a causal chain, the sequence of events, using methods such as interactions with other organisms, transfer of genetic material, or changes in use or management. Observations of indirect effects are often delayed (for example, if the target population of insects affects the reduction of insect populations or other multiple resistance or systemic effects of development to evaluate the long-term interaction; however, the indirect effects, such as reducing the use of pesticides could be immediate); 1.5.3. the immediate effects-have effects on human health or the environment, observed the proliferation of genetically modified organisms. Immediate effects may be direct or indirect (for example, death of insects foraging on transgenic plants that have kaitēkļrezistenc features, or allergies occur against people susceptible to it, if they are exposed to the genetically modified organism); 1.5.4. late effects are effects on human health or the environment which may not be observed in the distribution of genetically modified organisms, but in the form of direct or indirect influence in the distribution stage, or later at dissemination (for example, the introduction of genetically modified organisms or invasive behaviour after several generations living after deliberate release, which is especially important when genetically modified organisms are living long, or finds that close family transgenes cultural hybrids are becoming invasive in natural ecosystems); 1.6. the impact can be used in determining the appropriate measures, such as monitoring.
2. In accordance with the precautionary principle, risk assessment should be based on the following general principles: 2.1 identify the genetically modified organisms and the use of signs, which can cause adverse effects, compared with the non-modified organism characteristics and applications of which genetically modified organisms acquire and use appropriate, taking into account the following: 2.1.1. the base line of the receiving environment, including its organisms, their interactions and changes, fixed While not yet able to identify any (harmful) genetically modified organisms. The base line is a point of reference with which to compare future changes. For example, vegetative propagating culture comparative analysis should include parental species, from the transgenic lines. Crops with comparable values dzimumvairošano would be appropriate isogenic lines. If the crossing of cultural development, then it is important to check the essential equivalence suitable forms, rather than simply rely on comparisons with the original parent material; 2.1.2. If existing data is not enough, then the base line is determined by the different reference points, to perform the comparison. The base line is largely dependent on the receiving environment, including biotic and abiotic factors (e.g., saved natural habitats, agricultural land or contaminated land), or a combination of the different environmental conditions; 2.2. the risk assessment shall be carried out in a scientifically sound and transparent manner based on available scientific and technical data, taking into account the following: 2.2.1. potential adverse impact assessment should be based on scientific and technical data and the joint identification, collection and interpretation methodology. The data, measurements and checks clearly described. The missing data that is valid for risk assessment, obtained with a scientifically sound modelling procedures; 2.2.2. the risk assessment shall take into account the different levels of uncertainty. Scientific uncertainty usually arises from the five characteristics of scientific method: the chosen, the measurements made, the samples taken, the models used and the causal link. Scientific uncertainty may also arise from conflicting data or lack of relevant data. Uncertainty may relate to qualitative analysis or quantitative elements. The level of uncertainty about what should be reported to the applicant (inaccuracies, including the lack of data, lack of knowledge, standard deviation, complexity, etc., rating) reflect their level of knowledge or data relating to the baseline compared to scientific inaccuracies in an existing practice; 2.2.3. the risk assessment may not give definitive answers to all the questions under consideration due to lack of data. Data availability may be low, especially in relation to possible long-term effects. In these cases, special risk management (safety measures) should be dealt with in accordance with the precautionary principle, in order to avoid adverse effects on human health and the environment; 2.2.4. it may be useful to use a gradual approach (all stages of experiments restricted system to deliberate release, including the distribution of the market). The data at all stages of the procedure should be collected as soon as possible. Simulated environmental conditions in a limited system can make deliberate release significant results (for example, to a certain extent the behavior of the micro-organism can simulate a microcosm or plant behaviour – in greenhouses); 2.2.5. to spread of genetically modified organisms on the market, relevant and available data on the deliberate release into the environment, such that the genetically modified organisms intended for use; 2.3. the risk assessment shall be carried out for each individual case, which means that the required information may vary depending on the type of genetically modified organisms, their intended use and the potential receiving environment, taking into account, inter alia, genetically modified organisms, which are already in the environment. Take into account the following: 2.3.1. risk assessment uses the principle that each case is considered on its own merits so that there is a wide variety of organisms (genetically modified organisms) and various environmental conditions (certain area and certain regions) the range of characteristics; 2.3.2. genetically modified micro-organisms (because they are small and their interaction is often unknown), plants (for example, higher plants used for food and feed, or trees because of their potential longevity) and animals (e.g. insects, because they are small and they have a great ability of overcoming, or marine fish your high prevalence potential) can lead to very different effects on the environment; possible to 2.3.3 (site-specific or regional-specific) range of environmental attributes, which should be taken into account. To justify the assessment of the individual case, it may be useful to classify regional data by Habitat area, reflecting aspects of the receiving environment relevant to genetically modified organisms (for example, botanical data on genetically modified organisms, plant close to the incidence of wild species in different agricultural or natural habitats environments in Europe); 2.3.4. the genetically modified organisms to the harmful interaction with all concerned, genetically modified organisms, which may be deliberately released into the environment or the market in the past; also the same genetically modified organism redistribution, such as the use of plant protection products. Redistribution compared to occasional propagation at the time can cause a permanent increase of genetically modified organisms the background environment; 2.3.5. If genetically modified organism and its effects on human health or the environment as new information becomes available, then it may be necessary to repeat the risk assessment to determine whether 2.3.5.1.: the risk has changed; 2.3.5.2. determine whether the amendments are necessary, of risk management; 2.3.6. If new information becomes available, then irrespective of whether immediate measures must be taken, may be seeking a new risk assessment to assess the need to change the distribution of genetically modified organisms in the environment or market distribution authorization rules or customized risk management measures (see chapter V of these regulations). New information can be obtained from research or monitoring plans, as well as from relevant experience elsewhere; 2.3.7. risk assessment is closely related to monitoring. Risk assessment is the basis for the monitoring plans, which are associated with adverse effects on human health and the environment. the genetically modified organisms deliberate release monitoring plans differ from the requirements of the market of the genetically modified organisms for the monitoring plans for the market of the genetically modified organisms for specific monitoring, including general surveillance, may be important in obtaining the data, relating to genetically modified organisms possible harmful long-term effects. Monitoring results may confirm the assessment of the risks or suggest that a risk assessment should be reconsidered; 2.4. analyse the cumulative long-term effects (accumulated impacts on human health and the environment from genetically modified organisms circulate on the market, including the impact on flora and fauna, soil fertility, organic matter decomposition in the soil, the food chain, biological diversity, animal health and resistance problems associated with antibiotics, which refer to the expected distribution environment and distribution market): 2.4.1. assessment of potential cumulative long-term effects, the risk assessment shall take into account the following issues 2.4.1.1. the genetically modified organisms for prolonged interaction with the receiving environment; 2.4.1.2. the genetically modified organisms signs become significant in the long term; 2.4.1.3. deliberate release into the environment or market over a long period; 2.4.1.4. genetically modified organisms, which are deliberately released or distributed on the market in the past; 2.4.2. for lasting effects in particular may need further information (for example, multiple herbicide resistances), and have sufficient research, part of the monitoring plan system, which can provide important data on the cumulative long-term impact evaluation.
3. the Risk assessment shall take into account the relevant technical and scientific details of such genetically modified organisms: 3.1 characteristics of the uztvērējorganism or parental organisms; 3.2. genetic modification, whether due to genetic material or deletion, and relevant information on the vector and the donor; 3.3. the genetically modified organisms; 3.4. estimated distribution or usage and its scope; 3.5. the potential receiving environment; 3.6. the signs of interaction.
4. the Risk assessment shall take into account that information from releases of similar organisms and organisms with similar traits and their interaction with similar environments can assist the risk assessment. 5. before genetically modified organisms or genetically modified organisms deliberate release connection environment in accordance with the provisions of chapter IV, or distribution on the market in accordance with the provisions of chapter V of the report of the European Union, the competent authority of the Member State in which a distributed environment or in the market for the first time, and the application shall include the provisions laid down in annex 5 information (information about genetically modified organisms, donor, recipient, vector, the conditions of release and the environment genetically modified organisms, the interaction with the environment and the monitoring of genetically modified organisms).
Information about the recipient, donor, vector, genetic modification and genetically modified organisms on the basis of this provision, the information required in annex 5, is independent of the environment in which the experimental genetically modified organisms are released into the environment or the market, and from the circumstances in which the experimental disseminated or distributed on the market. Based on this information, identifying all potential hazards of genetically modified organisms (potential hazards-ability to harm human health or the environment or cause adverse effects to it). The knowledge and experience gained through the same or similar, genetically modified organisms can give important information on the possible distribution of the hazard in question.
6. Information about the intended release, receiving environment and their interactions, established in annex 3 of these regulations, applies only in the environment in which the spread of genetically modified organisms, and only on the conditions of release, including the distribution of its calibre. After all this information down the potentially harmful genetically modified organism characteristics. 7. make the conclusions of the risk assessment pursuant to these provisions, the main stages of the risk assessment considers the following: 7.1 the first stage. The identification of characteristics which may cause adverse effects; 7.2. the second phase. All adverse effects likely effect, if any, evaluation of impact; 7.3. third stage. All the identified possible harmful effects of probability assessment; 7.4. the fourth stage. The risk assessment of each identified genetically modified organisms in a sign; 7.5. the fifth stage. Application of management strategies for risks of genetically modified organisms deliberate release into the environment or distribution market; 7.6. the sixth stage. Genetically modified organisms, determination of the overall risk;
8. the analysis of the Risk assessment phase 1:8.1 identify all genetically modified organisms signs related to the genetic modification that may result in adverse effects on human health or the environment. The genetically modified organisms with no signs of the modified organism characteristics relevant to distribution or use, will assist in identifying the particular potential adverse effects arising from the genetic modification. Important not to discount any potential adverse effects on the grounds that its probability of occurrence is small; 8.2. the genetically modified organisms possible adverse effects in each case is different, and it may include: 8.2.1. human diseases, including allergenic or toxic effects; 8.2.2. animal and plant diseases, including toxic, and where appropriate, allergenic effects; 8.2.3. effects on the population dynamics of species in the receiving environment and the genetic of each of these populations;
8.2.4. altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or new source of infection, or vector formation; 8.2.5. negative impact on preventive or therapeutic medical, veterinary, or plant protection work, such as with the transfer of genes conferring resistance to antibiotics used in human or veterinary medicine; 8.2.6. effects on Biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen recycling organic matter decomposition in the soil; 8.3. many of the identifiable hazards (harmful characteristics) that can cause adverse effects, apply to the gene or the relevant genes, which are deliberately enter the genetically modified organism, the corresponding protein from these genes being expressed. Additional adverse effects, for example, pleiotropic effects can occur using a method for creating transgenic and structure to place genetically modified organisms which have been inserted in the genome of transgenes. If the receiver into more than one transgene or transgenes into genetically modified organisms, the potential interactions of transgene must be taken into account when considering possible epigenetic or regulatory impact; 8.4. to determine the hazard as accurately as possible, assess the usefulness to consider risks that are included in the following positions, and then specify the specific risks identified in the risk assessment purposes (for example, if the specific case identified adverse effects on human health as toksigenitāt, allergenicity and the risk assessment should be considered separately); 8.5. If genetically modified organism is dangerous, the danger is always there and is considered as an inherent property. The danger with a certain probability (step 3) can lead to negative consequences, which may have a different sequence (step 2). Genetically modified organisms in separate hazard collects summary; 8.6. consider only the dangers posed by the genetic modification that may result in harmful effects. Further risk assessment phase of the scientific basis is the 1st stage. At this stage it is essential to identify any indication of scientific uncertainty to be taken into account in any of the subsequent stages. Adverse effects may be direct or indirect and may arise following: 8.6.1. genetically modified organisms spreading environment: 8.6.1.1. genetically modified organisms could spread in the environment depends on, for example, from: 8.6.1.1.1. the biological suitability; 8.6.1.1.2. deliberate release into the environment or distribution market conditions (particularly the area of release and the scale, that is, the spread of genetically modified organisms); 8.6.1.1.3. deliberate release into the environment or in the distribution market, as well as a random distribution (such as processing, genetically modified organisms) probability; 8.6.1.1.4. how to wind, water, animals, etc. spreading the viable material (for example, seeds, spores, etc.); 8.6.1.1.5. Special (site-specific or regional-specific) environmental considerations: to assess each area or region alone, it may be useful to classify data by Habitat area, reflecting aspects of the receiving environment relevant to genetically modified organisms (for example, botanical data on genetically modified organisms, plant close to the wild krustojam the incidence of species in different agricultural or natural habitats of Europe); 8.6.1.2. assess the length of time an individual genetically modified organism or a certain number of particular species of genetically modified organisms usually survives and how it is able to spread and implemented in different habitats. Consider the reproduction, survival and dormant forms, including, for example: 8.6.1.2.1. plants: pollen, seeds and vegetative structures viability; 8.6.1.2.2. micro-organisms: spores as survival forms, or the viability of the micro-organism could be viable, but not linked; 8.6.1.3. total spreading ability can vary greatly depending on the species, genetic modification and the receiving environment, for example, plants cultivation of desert or fish cultivation; 8.6.2. the characteristics of transfer of genetic material to other organisms, or the same organism whether genetically modified or not: 8.6.2.1. hazards can cause adverse effects through gene transfer to the same species or other species (vertical and horizontal gene transfer). The speed and scale with which genes into other species (usually sexually compatible, as far as the higher organisms) will depend, for example, from: 8.6.2.1.1. the genetically modified organisms reproductive characteristics, including the changed order; 8.6.2.1.2. the conditions of release and the specific environmental considerations as climate (for example, wind); 8.6.2.1.3. the differences in the biology of reproduction; 8.6.2.1.4. agricultural practices; 8.6.2.1.5. the availability of the body that you can intersect; 8.6.2.1.6. the transport and pollinating vectors (for example, insects or birds, animals in General); 8.6.2.1.7. the availability of hosts not parasites; 8.6.2.2. the harmful effects of special creation, by gene transfer, can be associated with the spread of genetically modified organisms; 8.6.2.3. potential for gene transfer in large plant transgene fields can be completely different from the potential for gene transfer in small fields, even when weighted in proportion; 8.6.2.4. important qualitative and quantitative information about the uztvērējorganism or the possible existence of the organisms that can cross (plants relevant distances). Further distinction between higher plants and animals possible gene transfer to the same, closely related, remotely related and non-related species; 8.6.2.5. micro-organisms horizontal gene transfer is important. Some of the genetic material can be easily transferred between closely related organisms, such as plasmids or phages. Taking into account the ability of micro-organisms to grow quickly, they can provide a high level of gene transfer in comparison to higher organisms; 8.6.2.6. transfer of transgenes can occur mixed with time of the genetically modified organism or a combination of different populations of plant genes that, especially in the long run, can create complex adverse effects. The more transgenic material is transferred into a population (for example, the accumulation of genes), because the adverse effect is more complex; 8.6.2.7. in some cases, the method of genetic modification may alter the potential for gene transfer, such as if plasmids or viral vectors do not integrate. The method of genetic modification may also reduce the potential for gene transfer, for example, chloroplast transformation; 8.6.2.8. gene transfer may result in the genetic material of the persistence of natural populations. If genetically modified organisms has the potential for gene transfer, it doesn't always mean real risk or survival ability changes occur or adverse effects. It depends on the inserted genetic material, species and the receiving environment, including possible uztvērējorganism; 8.6.3. phenotypic and genetic instability: 8.6.3.1. consideration should be given to what extent genetic stability (in other cases, not stability) can lead to phenotypic stability (in other cases, instability) and dangers. Instability of genetic modification can in some cases cause a reversion to the wild phenotype. Other cases should be considered, such as: 8.6.3.1.1. or transgenic plant line that contains more than one transgene, the subsequent segregation process results in these transgenes being divided is, it could lead to plants with less transgenes but new phenotypes; 8.6.3.1.2. or attenuated mutants to instability (because of the structure of a particular mutation) revert to virulence; 8.6.3.1.3. or transgenes leads to gene duplication novājināšano; 8.6.3.1.4. or the number of copies is too large; 8.6.3.1.5. or transferable element inclusion in the repeat new phenotypes occur because of transgenic inactivates with the inclusion of mobile genetic elements; 8.6.3.1.6. or the level of expression of the transgene is important (for example, very little of toxic manifestation), and the regulatory element not stability may reinforce the transgene expression; 8.6.3.2. phenotypic instability can lead to interaction with the environment in the process of cultivation, so the risk assessment considering environmental and agronomic factors on transgene expression; 8.6.3.3. If transgenic expression is restricted to certain genetically modified organism passages (such as certain plant tissue), then the tuning instability can cause the transgene expression throughout the body. So consider important regulatory signals (for example, promoter); 8.6.3.4. considering also the expression of transgenic organisms in a specific life-cycle time or under specific environmental conditions; 8.6.3.5. genetically modified organisms can become infertile if it enters specific infertility transgenes (e.g. to prevent the transfer of certain transgenes and propagation). Infertility transgenes instability could be growing fertility restoration, allowing the spread of transgenes, which may have a harmful effect; 8.6.3.6. the different transgene stability is not only in the original genetically modified organisms, but also its progeny, particularly long-term effects; 8.6.4. interaction with other organisms (other than genetic material/pollen Exchange): 8.6.4.1. potential interactions with other organisms, including with other genetically modified organisms must be carefully assessed in the light of the complexity of the interactions between multitrofisk. Direct interaction of the hazards that may cause adverse effects include: 8.6.4.1.1. humans (such as farmers, consumers); 8.6.4.1.2. exposure to animals;
8.6.4.1.3. competition in relation to natural resources such as soil, water, light areas; 8.6.4.1.4. other natural populations of organisms extortion; 8.6.4.1.5. the release of toxic substances; 8.6.4.1.6. different growth patterns; 8.6.4.2. Typically, genetically modified organism can be invasive in new environments and displace existing species, if biological fitness improves, genetic modification. Often implementation specific exposure is proportional to the scope of distribution; 8.6.5. changes in management, where appropriate agricultural practices. Based on existing management procedures, assess how significant is the change management procedures that genetically modified organisms deliberate release is imminent. Changes in agricultural management can relate, for example, to: 8.6.5.1. sowing, planting, growing, harvesting or transport (for example, planting in small or large fields), timing; 8.6.5.2. crop rotation (for example, one species of plant growing every year or every fourth year); 8.6.5.3. disease or pest control (for example, type and dose of insecticide for plants, or antibiotics for animals, or the dose and equivalent measures); 8.6.5.4. resistance management (for example, type and dose of herbicide herbicīdizturīg plants or organic changes in the fight with the Bt proteins, or impact of viruses); 8.6.5.5. the isolation of farm or aquaculture systems (for example, isolation distances in plant cultivation or quality of isolation in fish farms); 8.6.5.6. agricultural practices (farming GMOs and non transgenic farming, including organic farming); 8.6.5.7. management systems, non-agricultural systems (for example, on the distances of natural habitats for the isolation of genetically modified organisms under).
9. Risk assessment analysis-2nd stage: 9.1. valued each of the possible harmful effects of the significance of effects. Valued not only potential harmful characteristics, but also the significance of the effects (the extent to which any naturally occur deliberately released or distributed on the market of genetically modified organisms the effects of potential adverse effects). The significance of valued relative to the base line and, taking into account that it may affect the following: 9.1.1. genetic structure; 9.1.2. each adverse effect identified; 9.1.3. the spread of genetically modified organisms (distribution scope); 9.1.4. the environment in which genetically modified organisms to be released; 9.1.5. distribution conditions, including control measures; 9.1.6. effects of these combinations; 9.2. assess each adverse effect identified, the consequences of which it leaves to other organisms, populations, species or ecosystems exposed to by genetically modified organisms. This requires detailed information on the environment (territory, region), in which the spread of genetically modified organisms, and distribution method. Consequences range from "negligible" or insignificant and self-limiting to "essential" or significant, which is immediate and serious adverse effects or long-term, permanent adverse effects; 9.3. If possible, the quantitative importance is assessed by a "substantial", "moderate", "low" or "negligible". In cases where it is not possible to identify harmful effects within an environment, the risks associated with the harmful effects can be evaluated with "trivial" or "insignificant"; 9.4. in the broad sense and qualitative explanatory examples, which are not intended to be final or exclusive role, but indicating the considerations which may be taken into account when assessing the consequences are as follows: 9.4.1. "significant consequences" is the significant changes in one or more species, including endangered and beneficial species, the number of organisms in the short or long term. Such changes may include a reduction of species or the destruction quite adversely affecting the ecosystems and/or other related ecosystems ' functioning. Such changes may not immediately be reversed, and any ecosystem recovery may be slow; 9.4.2. "moderate consequences" is the significant changes in population densities of other organisms, opposed the changes, which can cause complete destruction of the species or any significant impacts on endangered species or beneficial. Transient and fundamental changes in the population can be considered moderate consequences if they are reversible. The effect can be prolonged, if not a serious negative impact on ecosystem functioning; 9.4.3. "small effects" are those without significant changes in population densities of other organisms, which does not cause any other populations or species of organisms to complete destruction and which do not adversely affect the functioning of the ecosystem. The only organisms that can affect, is the body that in the short term or in the long term not belonging to the endangered species, which is not beneficial; 9.4.4. "negligible consequences" means that no one in the population, which is the environment, or the ecosystem not created major changes; 9.5. in paragraph 9.4 above examples reflect genetically modified organisms of potential adverse effects on the population. Atseviško cases may be more appropriate to consider the likely effects on individual organisms. One single hazard could have more than one adverse effect, and in fact every adverse impact significance can be different. The adverse effects of one single hazard on human health and agricultural and natural habitats can vary; 9.6. likely effect can create a summary, including all the ecological entities (such as species, populations, trophic levels, ecosystems), which can affect as well as the possible impact and level of uncertainty.
10. A Risk assessment analysis step 3:10.1. an important factor in the probability of adverse effects occurring is the evaluation of the environmental indicators that genetically modified organisms will be distributed, and the distribution type; 10.2. in assessing the risks, it is important not only to assess the significance of the effects of the hazards, but also to assess the probability of adverse effects occurring.
This phase assesses how great is the probability that the adverse effects actually occur. In some cases, paying attention to both the probability and frequency. As in step 2 (assess, what are the harmful effects of any possible consequences, if it occurs) to determine the probability, it is important to evaluate not only the hazards, but also the number of genetically modified organisms, the receiving environment and the circumstances of the release. Consider climatic, geographical, soil and demographic conditions, as well as the types of flora and fauna in the receiving environment may; 10.3. appreciate survive, regardless of the intended risk management measures proposed for deliberate release into the air or the market, it is appropriate to assess the proportion of genetically modified organisms that can survive. If there is a possible gene transfer, then consider the potential number of cases or transfer scope. If genetically modified organisms are pathogenic or toxic properties, then evaluate the proportion of target organisms in the environment that may be affected; 10.4. the emergence of probability of impact is dependent on the specific risk management measures to prevent the emergence of risk (for example, if pollen dispersal is impossible due to destruction of the inflorescence); 10.5. it is possible that each adverse effect identified, the relative probability of the consequences can not be evaluated quantitatively, but it can be characterized by "significant", "moderate", "low" or "negligible"; 10.6. the above examples reflect the genetically modified organisms to the possible adverse effects on populations, although in some cases it may be more appropriate to consider the likely effects on individual organisms. One single hazard could have more than one adverse effect, so any harmful effects of probability could also be different. The adverse effects of one single hazard on human health and agricultural and natural habitats can also vary; 10.7. the probability summary can be created to cover all the ecological entities (such as species, populations, trophic levels, ecosystems), also measures relating to the potential impacts, and the level of uncertainty.
11. the analysis of the Risk assessment phase 4:11.1 the risk posed by each identified characteristic of the genetically modified organism, which can cause adverse effects to human health or the environment, assess the relevant detail as possible, taking into account the level of knowledge and the combination of the harmful effects of probability of occurrence and the severity of the consequences if this effect occurs; 11.2. on the basis of the phase 2 and 3, each hazard identified in phase 1, assess the risk of adverse effects. A quantitative rating may not be possible. Each hazard evaluation considers the following factors: the seriousness of the consequences of 11.2.1. ("significant", "moderate", "low" or "negligible"); 11.2.2. the likelihood of the adverse effect ("high", "moderate", "low" or "negligible"); 11.3. If the hazard is more than one adverse effect, then any adverse impact and probability; 11.4. any genetically modified organisms considered separately. Any general attempt to quantify described above are treated with particular care. For example, in one case, the harmful effects of significant effects are combined with a negligible probability of occurrence over the range from high risk to a negligible risk. The result depends on the circumstances of the case and the way the applicant assessed the specific factors, all of which shall be determined and based on established risk assessment; 11.5. each identified risk in the total accuracy of the description, including documentation relating to: 11.5.1. different levels of risk assessment assumptions and extrapolations made; 11.5.2. different scientific assessments and viewpoints; 11.5.3. inaccuracies; 11.5.4. correction for known limitations of measures; 11.5.5. conclusions that can be derived from the data; 11.6. Although a risk assessment based on quantitative results, it is possible that many of the results of the risk assessments must remain high. But the relative risk assessment results (compared, for example, with non standard) should be obtained, even if they are of high quality.
12. the Risk assessment analysis stage 5:12.1. can identify risks that management implemented appropriate measures and determine the risk management strategy; 12.2. prior to applied risk management, preventive measure, considering the changes in distribution, preferably before the risk is negligible. For example, gene construction process avoids the genetic elements that can cause adverse effects or not identified. If this is not possible, give priority to the removal of these genetic elements from genetically modified organisms at a later stage to its deliberate release in nature or at a market; 12.3. it is taken into account from step 1 to step 4. Managing risk, identify risks and controls cover the inaccuracies. Security measures should be proportionate to the degree of risk and the level of uncertainty. If at a later stage become available relevant data, the risk management adapted according to new data; 12.4. to reduce the risk, the management of, the measures are such that reaching this goal precisely. For example, if there is a risk that the inserted gene in the crops to be carried over to the related species is toxic to plants, insects, then the appropriate control measures may be added to its isolation in space or time of these twin species or possibly distribution areas in selecting the areas in which the risk does not exist (for example, there is no such plant species); 12.5. management strategies may include isolation measures in all relevant genetically modified organisms and the use of the processing stages. They may also include various measures, including various means isolation, a generation physical or biological barriers and cleaning machines or containers that come into contact with genetically modified organisms, and other; 12.6. detailed risk management procedures are dependent on the following factors: 12.6.1. the use of genetically modified organisms (deliberate release or dissemination of market environment of the nature and scope); 12.6.2. genetically modified organisms (for example, genetically modified microorganisms, higher annual plant, higher long-life plant or animal, genetically modified organisms with one modification or more modifications, one or several types of genetically modified organism (s); 12.6.3. Habitat normally (for example, biogeochemical status, climate, of the same species or interspecific crossover, centres of origin, connection of different habitats); 12.6.4. type of agricultural Habitat (for example, agriculture, forestry, aquaculture, rural areas, size of sites, varying the number of genetically modified organisms); 12.6.5. natural habitat types (such as the saved state of the area); 12.7. clearly state the relation to risk management regarding the experiments necessary adaptations, the conditions for placing on the market and the like, as well as risk reduction, which should reach further.
13. A Risk assessment analysis 6. stage: 13.1. common genetically modified organisms in the risk assessment shall take into account any risk management strategies which are proposed; 13.2. based on phase 4. and 5. stage, carried out the final evaluation of the overall risk, including genetically modified organisms and harmful effects of probability based on the harmful effects of each risk, including other genetically modified organisms the cumulative effects. This final evaluation provides a summary of total risk (including common inaccuracies), the spread of genetically modified organisms on the market or the deliberate release into the environment.
14. In order to facilitate the preparation of the opinion on the possible impact on the environment, modified organisms or natural market distribution and on the basis of a risk assessment carried out in accordance with the principles and methodology set out in this annex, if necessary, the applications shall include the information contained in annex 2, paragraph 6 and 7. 15. Risk assessment is not static. Regularly reviewed and updated in light of new data. In considering any review of risk assessment and risk management in the quality and accuracy, taking into account the research, another deliberate release or in the monitor base data. It also depends on the risk assessment determined the level of accuracy. 16. Following any such revision, risk assessment and risk management as appropriate, adapted and improved. 17. Future developments in genetic modification may make it necessary to annex 2 of these regulations and these guidance notes be adapted to technical progress. Further differentiation of information requirements for different types of genetically modified organisms, such as single-cell organisms, fish or insects, or for particular applications of genetically modified organisms, such as the development of vaccines, may be possible when the Member States of the European Union will have accumulated sufficient experience in dealing with submissions pursuant to rule 5. the annex on certain genetically modified organisms.
Health Minister r. Muciņš annex 4 of the Cabinet of Ministers of 20 April 2004 the Regulation No 333 of Risk assessment of genetically modified organisms indicate the restricted use of a full risk assessment of genetically modified organisms for limited use in carrying out two procedures: 1. Procedure 1:1.1. genetically modified organisms, potential adverse effects: 1.1.1. identify possible genetically modified organisms harmful properties (hazard) and genetically modified organisms granted the original category (for categories 1 to 4) considering how important can be potential adverse effects; 1.1.2. the risk assessment identifies all genetically modified organisms harmful properties that result from genetic modification or other recipient of the transformation properties of the organism. Determine possible characteristics relating to genetically modified organisms. It is carried out, taking into account the recipient organism, the characteristics of the donor organism, and placed in the location of genetic material and any vector. It is important to assess whether the micro-organism genetic modification may affect the ability to cause harm to human health or the environment. Genetic modification may be reduced, remain unchanged or be increased capacity to cause injury; 1.2. the issues discussed: 1.2.1 recipient organism: 1.2.1.1. pathogenicity, virulence, infectivity, allergenicity, toxicity and vectors of disease; 1.2.1.2. the modified organisms used in creating vector and adventitious agents in a way where they can mobilise the inserted genetic material, and the frequency of mobilisation; 1.2.1.3 balance of activity type and persistence of mutations, if any; 1.2.1.4. all prior genetic modifications; 1.2.1.5. host range (if relevant); 1.2.1.6. all important physiological characteristics that could renew itself in the final of the genetically modified organism, and, where appropriate, their persistence; 1.2.1.7. natural habitat and geographic distribution; 1.2.1.8. meaningful participation in environmental processes (such as nitrogen fixation or pH Regulation);
1.2.1.9. interaction with other organisms in the environment (including likely competitive, pathogenic or symbiotic properties); 1.2.1.10. ability to form survival structures (such as spores or sclerotia); 1.2.2. the donor organism (for fusion experiments or experiments use random where the insert is not well described): 1.2.2.1. pathogenicity, virulence, infectivity, allergenicity, toxicity and vectors; 1.2.2.2. use vector types: sequence; 1.2.2.2.1. 1.2.2.2.2. frequency of mobilisation and specificity; 1.2.2.3. in the presence of genes which confer resistance to antimicrobial substances, including antibiotics; 1.2.2.4. host range; 1.2.2.5. other important physiological traits; 1.2.3. the insert: 1.2.3.1. the insert (genes) the specific identity and function; 1.2.3.2. the inserted genetic material manifestations; 1.2.3.3. the source of the genetic material, the taxonomic identity and, where appropriate, characteristics; 1.2.3.4. where appropriate, the prior history of genetic modification; 1.2.3.5. inserted the genetic material in the location (the possibility to activate/deactivate the inserted host genes); 1.2.4. vector: 1.2.4.1. nature and source of the vector; 1.2.4.2. vector and/or donor nucleic acid all the structure and the quantity remaining in the final construction of the modified micro-organism; 1.2.4.3. If genetically modified organisms in the final in a vector, the frequency of mobilisation and/or ability of transferring genetic material; 1.2.5. the genetically modified organisms: 1.2.5.1. with human health concerns: 1.2.5.1.1. the genetically modified organisms and/or its metabolic products toxic or allergenic effects; 1.2.5.1.2. a comparison with the modified micro-organism to the recipient or (where appropriate) parental organism regarding pathogenicity; 1.2.5.1.3. the colonization of ability; 1.2.5.2. If the organism is pathogenic to humans who are immunocompetent:. 1.2.5.2.1 induced diseases, prevalence and virulence mechanisms of transmission; 1.2.5.2.2. infective dose; 1.2.5.2.3. possible changes in infection or tissue specificity; 1.2.5.2.4. survival outside the human host; 1.2.5.2.5. biological stability; 1.2.5.2.6. the spectrum of resistance to antibiotics;
1.2.5.2.7. the allergenicity; 1.2.5.2.8. toksigēniskum; 1.2.5.2.9. appropriate therapies and prophylactic measures in existence; 1.2.5.3. environmental considerations: 1.2.5.3.1. ecosystems in which the micro-organism could be accidentally disseminated outside the restricted use; 1.2.5.3.2. the modified micro-organism viability, breeding and distribution volume in certain ecosystems; 1.2.5.3.3. the result of interaction between the modified micro-organism with the organisms or micro-organisms to which it may be exposed, accidentally outside environment; 1.2.5.3.4. known or predicted effects on plants or animals such as pathogenicity, toxicity, allergenicity, vector of pathogen, altered antibiotic resistance spectrum, altered tropism or host specificity, colonisation; 1.2.5.3.5. known or predicted involvement bioģeoķīmisko processes; 1.3. the initial classification of genetically modified organisms – risk of damage arising from all genetically modified organisms harmful characteristics, determine the importance of assessing the damage and any biological properties (e.g. mutations that reduce the activity), which limits the possibility of harm occurring. The significance of adverse effects be assessed independently from the harmful effects of probability. Any possible adverse impact significance is determined by considering what would be the effect, not whether such damage case might arise. For example, in the case of pathogens evaluated how serious should the disease assuming that susceptible species can infect. The genetically modified organism into the original category includes the evaluation of adverse effects. Genetically modified organisms created by the importance of the adverse effects on human health and the environment assessed properly; 1.4. the harmful effects of incidence estimation: 1.4.1 with containment measures comply with the originally assigned category, assess the potential harmful effects that may arise from exposure (both on the people and the environment) and the type of work and volume; 1.4.2. the major factor relating to the adverse effects of the incidence, it is, to what extent and how to people or the environment likely to be exposed to the genetically modified organism. The most important is to evaluate the exposure because it often depends on whether the adverse effect may occur. The likelihood of human and environmental exposure to genetically modified organisms, is independent of the operations that are performed (for example, the amount of the operation), and the initial classification under the limitation of actions; 1.4.3. the final classification and choosing control measures to take into account the specific nature of the operation. To assess the likelihood of a genetically modified organism can interact with people and the environment, taking into account the nature and volume of activity. It also affects the appropriate risk management procedures; 1.4.4. operation of the features which may affect the risk assessment and, where appropriate, be taken into account include the actual steps, working techniques, volume and control measures; 1.4.5. the evaluation of the special focus on waste and waste disposal. Where appropriate, implement the necessary security measures to protect human health and the environment; 1.5. nature of activities: 1.5.1. risks and control measures, which aim to reduce the genetically modified organism risks to the appropriate level will be influenced by the nature of the activities to, because they will affect human and environmental exposure and hence possibility of harm occurring; 1.5.2. activity type also determines where in the table in annex 5 to the appropriate containment and control measures; 1.5.3. in practice, work in the laboratory, standard laboratory procedures when the impact on exposure are well known, a detailed risk assessment for each individual procedure is not necessary if one does not use a very dangerous organism. A more detailed assessment requires procedures that are not commonplace or procedures, which could have a serious impact on the degree of risk, such as procedures that generate aerosols; 1.6. the concentration and volume: 1.6.1. cultural density may be very concentrated exposure to genetically modified organisms, in particular subsequent processing operations. Evaluate the impact of concentrations and adverse effects incidence; 1.6.2. when assessing the risk, account shall be taken of the amount. Can be one of the absolute amount of the operation or process, often repeat, since in both cases you may encounter increased likelihood of exposure if the containment and control measures are not given results and thus affects the likelihood of injury;
1.6.3. the high volume of work does not always mean high risk, higher volume can lead to increased risk of exposure to both people and the environment affected in terms of volume, which can occur if containment is not effective; 1.6.4. volume also determines which table in annex 5 to the appropriate containment and control measures; 1.7. growing conditions: 1.7.1. cultivation container or other equipment characteristics and form influence the degree of risk to human health and the environment. A high-tech suit sealed fermentation vessels can significantly reduce the effects of genetically modified organisms and thus risk. Important to assess the reliability of such equipment and possible failure rates, where efficiency can lead to harmful genetically modified organisms increased exposure. If this failure is reasonably expected to require additional containment measures. Standard operation procedures by persons who work with cultured GM organisms, such as centrifugation or sonication, all have a significant impact on the effectiveness of control measures; 1.7.2. in conjunction with physical culture conditions that act as containment measures, both biological and chemical measures used to protect nature, can significantly affect the necessary containment measures. Biological containment auksotrof to example is the mutant, which require special growth factors which ensure that growth happen. Chemical control can be applied disinfectant solutions used in drainage systems; 1.7.3. the environmental assessment has more important aspects, such as effects on the environment and nature and volume, or is it living organisms, which are in territory exposed, could cause harm to the genetically modified organism; 1.7.4. in assessing how the characteristics of the receiving environment will affect the possible harmful effects of probability and thus the degree of risk and control measures, where appropriate, take into account the following factors: 1.7.4.1. environment where you can interact with genetically modified organisms. Environment where you can interact with genetically modified organisms, usually will be limited to the workplace environment and territory, located just off the premises, but depending on the specific characteristics of the limited use of the premises and assess the wider environment. effects on the environment may depend on the nature of the activity and the volume, but to pay attention to all possible transitions to the wider environment. It can be physical (such as through the sewers , watercourses, waste disposal) and biological vectors created (for example, the infected animal or insect movement); 1.7.4.2. presence of susceptible species. The real risk of harm depends on the medium to which it is exposed, susceptible species, including humans, animals or plants; 1.7.4.3. genetically modified organism survival environment – to what extent genetically modified organisms can survive and resist the environment is serious risk assessment argument. If genetically modified organisms can survive in an environment where they could penetrate, damage likely will be considerably less; 1.7.4.4. impact on the physical environment – in addition to the direct harmful genetically modified organisms effects also assess indirect harmful effects resulting from significantly altering the physico-chemical and/or soil or water ecological balance of ingredients.
2. procedure: 2.1. final classification and containment measures: 2.1.1. repeating the first procedure, make sure that the final classification and containment measures are appropriate; 2.1.2. when all possible properties are reviewed with respect to their importance and incidence, having regard to the classification of the initial recipient specified in the containment and control measures the impact of genetically modified organisms can determine the final classification and containment measures. In determining the final classification and containment measures, the initial classification review to determine if it was correct, having regard to the activity and the nature of the proposed operation. Comparing the original classification and associated containment measures with the final category and containment requirements, you can get three results: 2.1.2.1. potential adverse effects that the original classification is not sufficiently taken into account, it would not be appropriate to take into account the temporary containment measures shall be assessed in accordance with the first procedure. So you need to apply additional containment measures and the possible revision of the classification of activities; 2.1.2.2. the initial classification was correct and applicable control measures sufficient to prevent or minimise harm to human health and the environment; 2.1.2.3. the initial classification of the higher category than required, thus the operation applied to a lower category and appropriate control measures; 2.2. final confirmation of conformity of control measures: 2.2.1. If the proposed final classification and containment measures, reassess the level of exposure to humans and the environment (procedure 1). This confirms that any adverse effects occurring, taking into account the nature and extent of the work and the proposed control measures, is sufficiently small. Once this is done, a risk assessment has been completed; 2.2.2. If the nature and extent of significant changes or becomes aware of new scientific or technical information, which risk assessment is no longer appropriate, the risk assessment will be reviewed in the light of the changes. All changes of measures arising from the risk assessment, applied forthwith to maintain adequate protection of human health and the environment; 2.2.3. genetically modified organisms to the proposed activities would be limited, according to classification, as well as the containment and control measures identified in the risk assessment, contained use activities to classify in categories 1 to 4. Containment and control measures for each category of rules laid down in detail in annex 5; 2.2.4. the genetically modified organisms in contained use activity classifications determined by the requirements of the Administration; 2.2.5. If there are any uncertainties about the final classification and containment measures, we recommend that you contact the genetically modified organisms to the Supervisory Board.
Health Minister r. Muciņš annex 5 of the Cabinet of Ministers of 20 April 2004 the Regulation No 333 genetically modified organisms in contained use safety measures 1. minimum equipment requirements, doing work in the laboratory: no PO box
Specification limit level 1 2 3 4 1.1.
The laboratory complex isolation 1 optional optional optional optional 1.2.
The conclusion of disinfecting the laboratory with steam not compulsory optional optional optional 1.3.
Surface resistant to water, acids, alkalis, solvents, disinfectants and cleaning products and is easy to clean (Workbench) mandatory mandatory mandatory (machines) (Workbench, floor) mandatory (Workbench, floor, ceiling, walls) 1.4.
Entry to laboratory via the Airlock 2 Optional optional optional optional 1.5.
Low pressure relative to the surrounding environment is optional optional optional optional, except darbības3 1.6.
In the laboratory and released into the air flowing through the filter with high efficiency HEPA4 of preservatives is optional optional optional using HEPA filters, exhaust air, except darbības3 required using HEPA filters and exhaust the hot air 1.7. equipment 1.7.1.
Laminar air flow boxing or special rooms to work with microorganisms is optional optional optional optional 1.7.2.
Autoclave building complex building specially suitable for 6 – two of the laboratory device which divides the work site 1.8. Work organisation 1.8.1.
Limited access to the workspace is optional optional optional optional 1.8.2.
A sign on the door, pointing to 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.
The shower is optional optional optional optional 1.8.5.
Protective clothing suitable protective clothing Suitable protective clothing (and optional safety shoes) suitable protective clothing for a complete change of clothing and footwear before entering the room and exit from the 1.8.6.
Gloves are optional optional optional optional 1.8.7.
Effective disease vectors (e.g., rodents and insects) control optional optional optional optional 1.9 1.9.1. waste.
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 optional optional optional optional 1 laboratory complex isolation – the laboratory is separated from the other rooms in the same building or is located in a separate building. 2 air locks, isolated space, through which get into the laboratory. Air locks in the clean part of the modified organism to the limited use of the isolated part lockable door with separate locker room or shower room. 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 terms "glasshouse" 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. 1. All the provisions referred to in paragraph 1 with the following additions: no PO box
Specification limit grade 1 2 3 4 building 2.1 2.1.1.
Greenhouse: a separate building 1 optional optional optional optional equipment 2.2 2.2.1.
Entry via Airlock with double doors optional optional optional optional 2.2.2.
Wastewater control optional optional to reduce the drain of 2 compulsory to prevent the drain of mandatory, to prevent a drain of work organisation 2.3 2.3.1.
The means to prevent unwanted species such as arthropods or rodents from entering mandatory Mandatory specimens required 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 greenhouse should be 1 is in a separate building, with a lockable door which closes with a watertight 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. All the conditions referred to in paragraph 1 with the following additions: no PO box
Specification limit level 1 2 3 4 3.1 equipment 3.1.1.
Animal housing insulation 1 optional optional mandatory Ob ligāt 3.1.2.
Vivārij bin 2, separated by lockable door optional compulsory Compulsory compulsory 3.1.3.
Vivārij compartment, designed to facilitate their treatment (waterproof and easily washable material cages, etc.)
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 appropriate norobežojumo, for example, cages, pens or tanks After check After check After check After check 3.1.6.
Filter isolator or isolated before space 3 optional optional optional optional 1 animal accommodation: building or a separate area of the building which has the facilities and other facilities such as changing rooms, showers, autoclave, food storage facilities. Vivārij partition: 2 rooms there vairojamo or animals used in experiments as well as premises used for simple surgical operations. 3 isolators: transparent in boxing, where small animals kept in cages or outside them; great for holding animals used in isolated rooms.
4. General and safety requirements for activities not mentioned above: no PO box
Specification limit level 1 2 3 4 4.1.
Viable micro-organisms should be placed in a system that provides process isolation 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 gas to 4.3.
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 materials 4.4.
The culture fluid of unfractionated inactivation before discharge from the closed system mandatory, optional with reasonable means mandatory, with reasonable means mandatory, 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 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.
The control area should be sealable to disinfected with steam not mandatory optional optional optional 4.8 equipment 4.8.1.
Entry via Airlock optional optional optional optional 4.8.2.
Easy to clean, water, acids, alkalis, solvents, disinfectants and cleaning products resistant surface Required (machines, if any) mandatory (machines, if any) mandatory (for machine tools, if any, floor) mandatory (machines, floor, ceiling, walls) 4.8.3.
Special features to sufficiently ventilated area controlled and reduce air pollution by choice After choice After choice necessarily 4.8.4.
Air pressure control area reduced in relation to the surrounding environment is optional optional optional required 4.8.5.
The control area and the air escapes through the HEPA filter optional optional required (exhaust air, optionally, inlet air) required (inlet and exhaust air) 4.9 4.9.1 the labour organisation.
Closed systems are located in the control area optional optional optional optional 4.9.2.
Access allowed only to certain personnel not required required required required 4.9.3.
Before leaving the control zone personnel should be showering optional optional optional optional 4.9.4.
Personnel should wear protective clothing required (working) required (working) required a complete makeover before entering the room and exit from its waste 4.10.1 4.10.
Genetically modified organism inactivation source of 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. users with the permission of the Council may adjust the application of the security measures, which corresponds to a given containment level or combine different grades appropriate measures. 2. the table in the "optional" means that the user can perform these measures in certain cases according to the assessment.
Health Minister r. Muciņš annex 6 of the Cabinet of Ministers of 20 April 2004 the Regulation No 333 application of genetically modified organisms deliberate release into the environment and dissemination of market information appearing i. General questions 1. Chapter II of this annex shall apply to all types of genetically modified organism (hereinafter referred to as the modified organisms) on the deliberate release into the environment of the distribution market, with the exception of genetically modified higher plants (higher plants).
2. Chapter III of this annex shall apply to higher plants on the deliberate release into the environment of the distribution market. 3. Higher plants under the terms of this plant, belonging to the flowering plant (gymnospermae) and kailsēkļ (angiospermae) taxonomic groups. 4. The application does not always fall all the requirements in this annex. The specific content of the application consistent with genetically modified organisms and the new food Supervisory Board, in the light of each individual case according to the observations.
II. Application of the modified organism (except for higher plants) for distribution 5. General information 5.1 the applicant: name, surname, address (legal person – name and address); 5.2. the responsible scientist name, qualifications and experience; 5.3. the name of the project.
6. information relating to the modified organism: 6.1 the donor, recipient or (where appropriate) parental organism characteristics: 6.1.1. scientific name; 6.1.2. taxonomic affiliation; 6.1.3. other names (for example, the common name, the name of the variety); 6.1.4. phenotypic and genetic characteristics; 6.1.5. the donor and recipient of the degree of relationship or the degree of relationship with the parental organisms; 6.1.6. the modified organism detection and identification methods; 6.1.7. the modified organism detection and identification methods for sensitivity, reliability (in quantitative sense) and specificity; 6.1.8. the modified organism to geographic distribution and description of the natural environment, including information on natural enemies, objects, parasites and competitors, symbionts and hosts; 6.1.9. potential for genetic transfer and exchange of information with other organisms; 6.1.10. the genetic stability of the organisms and factors affecting assay; 6.1.11. pathological, ecological and physiological traits: 6.1.11.1. hazard classification; 6.1.11.2. life expectancy in natural ecosystems, sexual and bezdzimumvairošan cycle; 6.1.11.3. information on survival, including adaptation to climate change and the ability to form survival structures under adverse environmental conditions, such as seeds, spores, sclerotia; 6.1.11.4. pathogenicity: infection, toxicity, virulence, allergenicity, pathogen vectors (vector), possible vectors, host range including the optional host. Latent virus (provirus) possible activation. Ability to colonise other organisms; 6.1.11.5. antibiotic resistance and possible antibiotic substances concerned people and domestic animals in the prevention and therapy;
6.1.11.6. participation in environmental processes, such as primary production, nutrient circulation, decomposition of organic substances in the process, breathing; 6.1.12. modified organism used in creating vector characteristics: 6.1.12.1. sequence; 6.1.12.2. frequency of mobilisation; 6.1.12.3. specificity; 6.1.12.4. and other antibiotic resistance genes; 6.1.13. information on earlier modifications made the genetic modification; 6.2. vector Description: 6.2.1 vector structure and origin; 6.2.2. transposable, vector and other genetic sequence of fragments, which are used to create the modified body concerned pārnesoš of the vector in the new genetic material delivered; 6.2.3. use vector in genetic frequency of mobilisation or genetic transfer capabilities and methods of determination;
6.2.4. information about the function, the required minimum vector DNA structure; 6.3. characteristics of the modified organism: 6.3.1. information relating to the genetic modification: 6.3.1.1. used for the genetic modification techniques; 6.3.1.2. the methods used to create and deliver the recipient inserts or to cause the deletion of DNA nucleotide sequence; 6.3.1.3. the insert or the vector construction; 6.3.1.4. the unknown presence of nucleotide sequence of the insert option structure and information about the function, the required minimum vector DNA structure; 6.3.1.5. the modified, inserted, or removed the fragment of nucleic acid sequence, functional identity and location of the genome, in particular in relation to the modified organism to any possible dangers; 6.3.2. information about the resulting modified organisms: 6.3.2.1. genetic traits or phenotypic traits, especially new traits and characteristics which may be expressed in the modified organism or expression; 6.3.2.2. any vector or donor nucleic acid structure and the quantity that remains in the final design in the modified organism; 6.3.2.3. genetic stability of the organism; 6.3.2.4. the expression of the new genetic material and level of intensity. Measurement method and sensitivity; 6.3.2.5. synthesised protein (protein) activity; 6.3.2.6. isolation and identification methods, including techniques for the identification of the insert and vector and isolation; 6.3.2.7. isolation and identification of methods of sensitivity, reliability (in quantitative sense) and specificity; 6.3.2.8. information on the previously modified organisms or usage; 6.3.2.9. health-related observations: 6.3.2.9.1. not living modified organisms or their metabolic products toxic and allergenic effects; 6.3.2.9.2. modified organisms and products containing the hazard; 6.3.2.9.3. a comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity; 6.3.2.9.4. the colonization of ability; 6.3.2.9.5. If the organism is pathogenic to people with normal immune systems: 6.3.2.9.5.1. izraisām and the pathogenesis of the disease mechanism, including invazivitāt and virulence;
6.3.2.9.5.2. infectivity; 6.3.2.9.5.3. infective dose; 6.3.2.9.5.4. host range and change; 6.3.2.9.5.5. the possibility of survival outside of human body; 6.3.2.9.5.6. the presence of vectors or other dissemination of the options; 6.3.2.9.5.7. biological stability; 6.3.2.9.5.8. antibiotic resistance spectrum; 6.3.2.9.5.9. the allergenicity; 6.3.2.9.5.10. availability of appropriate treatment methods.
7. the dissemination of GMOs and the environment: information on the distribution of 7.1:7.1.1. Description of planned deliberate release, including the purpose and available products; 7.1.2. the expected distribution date and the planned time of the experiment, including the frequency and duration of the release; 7.1.3. the site of the original preparation; 7.1.4. the size of the release site; 7.1.5. the methods used in the distribution; 7.1.6. distributable quantity of GMOs; 7.1.7. changes for the site (type and method of processing, modification of the composition of soil, irrigation, or other activities); 7.1.8. distribution to the employee at the time of protection measures; 7.1.9. processing of the site after the modified organisms of operation will be completed. 7.1.10. the Elimination of the modified organism or suspension of operations at the end of the experiment; 7.1.11. preliminary results of the modified organisms and information about them, especially the information about their distribution in different quantities and different ecosystems; 7.2. information on the environment (on the distribution site and wider surroundings): 7.2.1. the geographical location of the site, and coordinates (in the application of the modified organism to market the site is intended for use in the product area); 7.2.2. the physical and biological proximity to humans, flora and fauna; 7.2.3. the distance to the habitats or protected areas; 7.2.4. the population; 7.2.5. the economic activity of the population, based on the natural resources of the area; 7.2.6. the distance to the closest protected drinking water sampling sites and specially protected areas; 7.2.7. climatic characteristics of the district, who may be affected; 7.2.8. geographical, geological and soil characteristics; 7.2.9. flora and fauna, including crops, livestock and migratory species; 7.2.10. the target and additional ecosystem that may be affected; 7.2.11. host's natural place of residence and the comparison of distribution; 7.2.12. any known planned developments or changes in land use or the modified organism distribution site that could influence the distribution of space environment. 8. Modified organisms and environmental interactions: 8.1. a description of the conditions which affect the ability of the modified organism to survive, proliferate and spread: 8.1.1. biological features which affect survival, the modified organisms reproduction and distribution; 8.1.2. known or predicted environmental conditions which may affect survival, the modified organisms reproduction and distribution (such as wind, water, soil, temperature, pH); 8.1.3. sensitivity to specific exposure factors; 8.2. effects on the environment: 8.2.1. for the modified organisms; 8.2.2. studies on the behavior of the modified organism, and their ecological impact carried out in a natural environment, but not, for example, climate Chambers, production rooms, greenhouses; 8.3. genetic transfer options: 8.3.1. genetic material at a later date (after the distribution) transfer of the modified organism to other organisms in the ecosystem concerned; 8.3.2. genetic material at a later date (after the distribution) transferred from indigenous organisms to the GMOs; 8.3.3. the probability that after distribution of the modified organism natural selection can result in unexpected or unwanted characteristics of expression of the modified organism; 8.3.4. the measures taken to ensure and demonstrate the genetic stability. The description of genetic trait that can prevent or reduce the spread of genetic material. Methods used to show the genetic stability; 8.3.5. biological pathways, known or potential modes of interaction and the spread of enabling factors, including, for example, inhalation, intake, surface contact; 8.3.6. Description of ecosystems to which the modified organisms could be distributed; 5.2. possible effects of GMOs on the environment: 8.4.1. excessive population formation; 8.4.2. the advantages of the modified organism with no competition for modified recipients or parental organisms; 8.4.3. the target organism identification and description; 8.4.4. the modified organism and target organism intended interaction mechanism and result; 8.4.5. the identification of organisms, and which may be affected by accident; 8.4.6. the distribution by modified organisms possible changes in biological interactions or in hosts; 8.4.7. known or predicted effects on other organisms in the environment, impact on population levels of competitors: preys, hosts, symbionts, not predators, parasites and pathogens, 8.4.8. known or predicted involvement on biogeochemical processes; 8.4.9. other potentially significant effects of modified organisms. 9. information about monitoring activities (monitoring), control, waste treatment and action plans in critical situations: 9.1. monitoring (monitoring) techniques: 9.1.1. methods for the marking of GMOs and their related impacts monitoring (monitoring); 9.1.2. surveillance methods, sensitivity, specificity and reliability to identify the GMOs, and differentiate them from the donor, recipient or between parental organisms; 9.1.3. techniques to detect the modified transmission of genetic material to other organisms; 9.1.4. the monitoring duration and frequency of control measures; 9.2. emergency response plans: 9.2.1. techniques and methods to prevent or reduce the spread of the GMOs beyond the site of release or a specific area of use; 9.2.2. techniques and methods to protect the modified organisms and does not penetrate the outsiders; 9.2.3. techniques and methods to prevent other unwanted organisms from entering the site; 9.3. waste treatment: 9.3.1. waste types. 9.3.2. expected amount of waste; 9.3.3. possible risk factors; 9.3.4. proposed waste treatment; 9.4. action alert: 9.4.1. methods and procedures to be used for the control of GMOs, where their uncontrolled spread; 9.4.2. the methods used for conditioning and rehabilitation of the area; 9.4.3. methods of dissemination of GMOs during or after in order to remove or sanitary handle exposed plants, animals, soil; 9.4.4. methods for the isolation of the area occurred in the modified organism; new item 9.4.5. the protection of human health and the environment action plan in case the modified organisms occurs during unwanted consequences.
III. the application of higher plants for distribution 10. General: 10.1. the applicant's name, address (legal person – name and address); 10.2. the responsible scientist name, qualifications and experience; 10.3. the name of the project.
11. information relating to the recipient or (where appropriate) parental plants: 11.1. full name: family, genus, species, subspecies, varieties and cultivars/common name; 11.2. the relevant information concerning reproduction: 11.2.1. breeding; 11.2.2. Special reproduction factors affecting, if any; 11.2.3. generation time; 11.2.4. sexual compatibility with other cultivated or wild plant species; 11.3. survivability: 11.3.1. ability to form survival structures or over-wintering; 11.3.2. survival-in particular, if any; 11.4. seeding seeding: 11.4.1. the types and quantity, such as assessment of how viable pollen and/or seeds declines with distance; 11.4.2. the particular an-izsēšano, if any; 11.5. the geographical distribution of plants; 11.6. If the species of higher plants are grown in the Member State in which the dissemination of GMOs, plant natural Iza site description of the area, including information on natural enemies, parasites, competitors and symbionts; 7.3. the plant possible significant interactions with other organisms in the ecosystem where it is usually plant, including information on toxic effects on humans, animals and other organisms.
12. the information that describes the genetic modification: 12.1. Description of the methods of genetic modification; 12.2. use vector type and origin; 12.3. the donor organism's size, origin, taxonomic affiliation (name), modifications in the genome and its function.
13. information that characterize higher plants: 13.1. characteristics of the inserted or modified; 13.2. information about inserted or removed in the sequence: 13.2.1. inclusion or deletion, size and structure, as well as modification of the method used, including information on the genetically modified plant hybrids created by using the vector or any other part of the vector molecules in plant conservation modified; 13.2.2. where the deletion is made, cut the size of the fragment and the function; 13.2.3. inclusion of the site located in the plant cells (integrated in the chromosome, chloroplast, mitochondrial DNA, or stored in a non-integrated form), as well as its methods of determination;
13.2.4. Insert the number of copies; 13.3. information about the inserted genetic information expression: 13.3.1. information about the type of expression of the insert and its characterization methods; 13.3.2. upper part of the plant where the insert is manifested (such as roots, stem, pollen); 13.4. the growing disparity of the recipient plant, taking account of: 13.4.1. the type or intensity of breeding; 13.4.2. seeding ability; 13.4.3. survivability; 13.5. genetic stability of the insert and phenotypic stability of the plant; 13.6. the possibility of transfer of genetic material from plants to other organisms; 8.5. information on any toxic, allergenic or other harmful effects on human health and the environment arising from the genetic modification process; 8.6. information on highest plant safety to animal health, particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the higher plant is intended for use in animal feed; 13.9. If possible, characterise the highest plant and target organisms interaction mechanism; 13.10. the possible important interactions with other organisms; 13.11. the highest plant detection and identification methods; 13.12. information on similar higher plants distribution experience, if any.
14. information on the highest place of the release (only for applications for GMOs for deliberate release into the environment): 14.1. release site placement and size; 14.2. the description of the release site ecosystem, including climate, flora and fauna; 14.3. a related wild or cultivated plant species, in the presence of plant species that are able to cross with the modified organism; 14.4. the distance to the protected habitats or areas that may be affected by the modified organisms.
15. information relating to the distribution of higher plants (only for applications for GMOs for deliberate release into the environment): 15.1 for the purpose of dissemination; 15.2. the distribution date and duration; 15.3. the method by which the genetically modified plants were distributed; 15.4. the method of distribution and control site preparation prior to, during and after it, including cultivation and harvesting methods; 15.5. approximate number of higher plants (or plants per square metre).
16. Control and surveillance measures at the highest plant distribution and waste treatment (only for applications for GMOs for deliberate release into the environment): 16.1. precautions: 16.1.1. determination of distance to habitats that occur with the higher plant species are sexually compatible; 16.1.2. any measures to reduce or eliminate the highest plant pollen or seed distribution; 16.2. processing of space at the top of the release description of the methods used; 16.3. higher plant material (including waste) processing methods to be used (after their distribution); 16.4. surveillance (monitoring); 16.5. the emergency measures.
17. The distributable modified organism to potential impacts on the environment: 17.1. likelihood of agricultural spread in the environment of higher plant becomes more stable than the recipient or parental plants or get more distribution capacity of the natural environment; 17.2. any selective advantage or interference that can cause transfer of genetic material from the top of the plant to other sexually compatible plant species; 17.3. If necessary, the higher plant and target organisms, the interaction potential impacts on the environment; 17.4. higher plants and other organisms interactions the potential impact on the environment. Health Minister R. Muciņš Annex 9. Cabinet of Ministers of 20 April 2004 the Regulation No 333 additional information to be included in the application and the labelling of genetically modified organisms in the application of genetically modified organisms (hereinafter referred to as the modified organisms) or the distribution of the products on the market, as well as the provisions in chapters III and IV and the 58 cases referred to in paragraph 6 in addition to these provisions. the information mentioned in the annex specifies the following information: 1. this annex describes in general terms the additional information that must include: 1.1. application modified organisms or their products on the market; 1.2. the labelling of products distributed on the market, containing or consisting of them; 1.3. the labelling of products which comply with the provisions of chapter III and paragraph 58 of the cases referred to on the label or in an accompanying document to provide clear information on the presence of GMOs. For this purpose, on a label or in an accompanying document is the words "this product contains genetically modified organisms". These products provide recommendations and restrictions on use.
2. the application of the modified organism or products thereof for distribution market in addition to the provisions referred to in annex 3 information indicates the following: 2.1 the trade name of the product and that it contains the name of the modified organism, any specific designation, name or code used by the notifier to identify the modified organism; 2.2. The European Union registered a personal first name, last name, address (legal person – name and address), which is responsible for the distribution of the market, whether it be the manufacturer, the importer or the Distributor; 2.3. control the applicant's name, address (legal person – name and address); 2.4. a description of how a product containing or consisting of those for use. Highlights the differences between organisms and similar non-genetically modified products in use and management; 2.5. the geographical area or media type, in which the product is intended for use, if possible, include details of the expected usage level; 2.6. the intended use, such as industry, agriculture, trade-specific or unlimited distribution, retail; 2.7. information about genetic modification, modifications in organisms register records that can be used to modify certain product detection and identification. This information, if necessary, indicate the competent authority, in which the modified organism or its genetic material and details of nucleotide sequences or other types of information that is required to identify the modified organism product and its progeny, such as modified organism product discovery and identification methodologies, including experimental data, which show the specificity of the methodology. Identifies information that for reasons of confidentiality can not be placed in the public part of the register; 2.8. proposed labelling on a label or in an accompanying document. The label says, how to access information at the registry part that is available to the public. The labelling shall include, at least in summary form: 2.8.1. the trade name of the product; 2.8.2. notes that "this product contains genetically modified organisms/s/s"; 2.8.3. the name of the modified organism; 2.8.4. information referred to in point 2.2.
3. in addition to paragraph 2 of this annex, the information shall, if necessary, specify the following information: 3.1. protection measures are not controlled or modified organisms of the distribution; 3.2. specific instructions or recommendations for storage and GMOs other activities with them; 3.3. special instructions on monitoring in accordance with the monitoring plan; 3.4. proposed restrictions permit the use of GMOs, such as the use of the product and for what purposes; 3.5. expected form of packaging. Packaging must be such as to prevent inadvertent modified organisms spread it during storage and distribution; 3.6. estimated production in and/or imports to the European Union; 3.7. for additional labelling. This compilation includes at least 2.4., 2.5., 3.1., 3.2., 3.3 and 3.4. information referred to in point.
Health Minister r. Muciņš annex 10 of the Cabinet of Ministers of 20 April 2004 the Regulation No 333 instructions for drawing up and monitoring plan monitoring procedures i. General Part 1 of this annex supplements the information contained in chapter VI of this regulation, with the following instructions: 1. for monitoring purposes; 1.2. the General principles of monitoring; 1.3. provide the overall framework of the plan, drawn up by the monitoring of the sale of genetically modified organisms.
2. After the dissemination of genetically modified organisms on the market, the notifier under these provisions is a legal obligation to provide monitoring and reporting under the conditions specified in the monitoring of genetically modified organisms in the Council decision. 3. the Monitoring plans for the dissemination of genetically modified organisms on the market certainly develop on a case-by-case basis, taking into account the risk assessment, the genetically modified organism-specific change characteristics, intended use and the receiving environment. 4. Efficient and overall monitoring develop appropriate methodologies that are available before the start of the monitoring programme. Monitoring by itself may not be considered to be in the research, but the results and as a means to evaluate or verify the presumption resulting from previous research and evaluation of possible risks.
II. Aim 5. In accordance with the provisions set out in chapter VI of the sold monitoring genetically modified organisms aims: 5.1. confirm that all risk-assessment assumptions relating to the genetically modified organism or its usage potential adverse effects and consequences are correct; 5.2. identify the genetically modified organism or its use, adverse effects on human health or the environment and is not for the risk assessment.
III. General principles 6. Monitoring set out in chapter VI of these provisions and in the context of this annex, apply to sales of genetically modified organisms, comes after the authorised genetically modified organisms on the market. 7. Planning is essential for all types of monitoring, and developing monitoring plans, and specific monitoring should be considered in certain cases and the overall monitoring. In addition, the possible cumulative effect of monitoring that is lasting, considered as a compulsory part of the monitoring plan.
8. Specific monitoring that included in the monitoring plan, focus on their potential impact caused by genetically modified organisms and which are set out on the basis of the risk assessment conclusions and assumptions. However, on the basis of a risk assessment and scientific information available, it is possible to predict certain effects, but is vastly more difficult to plan for potential impacts or variable values, you cannot predict or anticipate. However, the monitoring plan accordingly, you can optimize such impacts timely disclosure. Therefore the monitoring plan included unpredictable or unexpected adverse impact overall monitoring.
9. In connection with the preceding paragraphs shall take into account the specific monitoring and overall monitoring cost effectiveness. In addition, a plan for monitoring in accordance with the latest scientific knowledge and practice. 10. interpretation of the monitoring data collected shall take into account the existing environmental conditions and activities that focus on the appropriate baseline. Similar can be useful for general monitoring and environmental monitoring programs. If the environment is observed unexpected changes, then consider the need for further risk assessment to determine whether they are genetically modified organisms on the market or other factors in performance. It must also be considered in relation to measures for the protection of human health and the environment.
IV. the design of the Monitoring plan 11. The Monitoring plan has the following three main sections: 11.1. monitoring strategy; 11.2. the monitoring methodology; 11.3. analysis, reporting, review.
12. The Monitoring strategy is important to determine the potential effects that may arise from the dissemination of genetically modified organisms on the market, the degree to which they are to be monitored, as well as the appropriate method (s) (I) and the monitoring period (s). 13. Consider how great is the probability that genetically modified organisms will result in direct, indirect, immediate or delayed adverse effects, taking into account its intended use and the receiving environment. 14. the Direct impact of the genetically modified organism the primary effects on human health or the environment, which does not occur through a causal chain of events. For example, with regard to culture, modified for resistance to certain insects, the direct impact caused by genetically modified organisms produced toxin, can include both the insect death and changes in the population, which is the target insects and not target insects. 15. the indirect effects are the effects on human health or the environment occurring through a causal chain of events. For example, in the above case indirect effects may occur if the target population of insects affects the reduction of populations of other organisms that normally feed on these insects. 16. the indirect effects may include more interaction between the organism and the environment, and it complicates the forecasting of potential impacts. Observations of indirect effects may also be delayed. However, these factors are considered as part of the strategy. 17. the immediate impact is the effects on human health or the environment, observed the proliferation of genetically modified organisms. Immediate effects may be direct or indirect.
18. the impact of Delayed effects on human health or the environment which may not be observed in the distribution of genetically modified organisms, but becomes noticeable direct or indirect impacts on later stage or when the distribution is over. Delayed impact example is the development of resistance to Bt toxins in insects, where they are exposed to prolonged periods of time. 19. the immediate and delayed effects may be direct or indirect, but it can involve differences in the periods. Direct effects detectable level would most likely occur immediately or within a short time. Indirect effects of the expression may be necessary for a longer period, however, it is taken into account. 20. It is very difficult if not impossible to predict an expected or unexpected effects that are not described in the risk assessment. So the potential unforeseen or unanticipated impact of general monitoring is considered as part of the monitoring strategy. 21. Risk assessment.
The monitoring strategy, as determined in accordance with the usage of genetically modified organism and the receiving environment confirms the ratings obtained in risk assessment. This takes into account the conclusions of the risk assessment and assumptions, which are based on scientific evaluation and the recommendations of the Committee of experts. In addition, issues arising from the risk assessment, which is to some extent unclear, for example, about the potential effects that may occur, the distribution of a large scale, also includes the monitoring strategy as its ingredients.
22. General information.
Planning and monitoring plan development can use all general information relating to the genetically modified organism, including data and information obtained from the experimental distribution, from scientific publications and relevant comparable evidence obtained in another distribution. In this regard, particularly valid is the data obtained from the available risk research and pilot monitoring of distribution.
23. the method: 23.1. describe method of monitoring strategy. In many cases, it concentrated on the major concerns (to know) and cyclic monitoring process, to continuously improve the quality; 23.2. the method provides a means by which to discover potential harmful effects in early stage of expression. Of any genetically modified organism-related adverse effects early detection enables faster re-evaluate and implement measures to reduce the consequences of any environment; 23.3. the genetically modified organisms for monitoring plans by the step-by-step methods, taking account of existing data and monitoring methodology. Step-by-step method in many cases also takes into account the amount of the distribution. You can create the first period, based on the evidence obtained in an experimental trial of successive stages, based on large-scale field trials and ultimately to surveys in agricultural land. Experience and information obtained from the genetically modified organisms through the monitoring of experimental releases of, can be useful in designing the genetically modified organism the monitoring mode is planning needed to spread of genetically modified organisms on the market; 23.4. the genetically modified organisms for monitoring needs can also customize existing monitoring programs to ensure comparability and limited resource expenditure methods. This applies to existing environment observation programmes in agriculture, food surveys, nature conservation, long-term ecological monitoring programs, soil observation and veterinary studies. Such programs for inclusion in the monitoring plan, first and foremost, appropriate application of agreements with persons or organizations, including the national authorities that govern such work; 14.6. This section focuses on specific monitoring and monitoring of General under two general objectives set in accordance with the provisions of Chapter VI, but without disrupting other monitoring systems.
24. specific monitoring specific cases.
Specific monitoring specific cases used to confirm that it is properly reasoned assumptions that the risk assessment refers to the possible adverse effects caused by genetically modified organisms and their uses: 24.1. special monitoring method: 24.1.1. focus on all the potential effects on human health and the environment and identified in the risk assessment, i.e., taking into account the different locations, soil types, climatic conditions; 24.1.2. determine the exact period during which the results obtained; 24.2. the first stage in the development of the plan for the monitoring of certain specific cases is to determine the objectives of the monitoring strategy for specific cases. Also determine which assumptions about the genetically modified organism or its possible harmful effects the use of incidence and impact are set out in the risk assessment, and it confirms with the specific monitoring. If the conclusions of the risk assessment has identified the absence of risk or negligible risk, then there is no specific monitoring specific cases; 24.3. potential adverse effects identified in the risk assessment, included in the monitoring plan, only on the basis that monitoring can play a role in the approval or rejection of the assumption that relates to this effect; 15.2. If the intended use of the genetically modified organisms include cultivating, then you should consider monitoring of risks arising from pollen transfer, this proliferation of genetically modified organisms and the resistance. The degree to which there is a probability that this phenomenon also depends on the amount of use and the receiving environment, including sexually compatible conventional cultivated species and related species of wild and near; 15.2. the potential environmental risks posed by genetically modified organisms, which are approved only for import and processing, can often appreciate and completely restrict, if genetically modified organisms intentionally enter the environment if they are not typically spread; 24.6. potential impact on human health or the environment arising from the release of genetically modified organisms into the environment or the market is dependent on the distribution of genetically modified organisms and its specific intrinsic genetic modifications. For example, the possible impacts caused by the transfer of pollen from genetically modified crops to non-genetically modified crops or related wild plants, depends largely on whether the genetically modified crop, intersect or self-pollinating. In this respect, also consider a related wild plants;
24.7. all subsequent impacts, such as the possible development of resistance to Bt toxins in insects, is only related to genetically modified organisms, modified this specific toxin. Otherwise is to genetically modified organisms, modified only for herbicide resistance, since these genetically modified organisms does not contain Bt toxin gene; 15.4. it is also important to monitor possible antibiotic resistance gene transfer and possible implications for genetically modified organisms, which contain antibiotic resistant modification of selected gene; 15.5. After target detection based on the potential harmful effects, the next stage is the identification of the parameters measured, in order to achieve these objectives. The parameters and the methods of measurement and evaluation must be valid and appropriate for this purpose.
25. General monitoring: 25.1. General monitoring is largely based on periodic observation ("look, see!"), and it is used to identify genetically modified organisms unpredictable adverse effects or usage that is not projected to the risk assessment, but is harmful to human health and the environment. It includes observation of phenotypic characteristics, but does not exclude more detailed analysis; 25.2. in contrast to the special monitoring, in certain cases, the general monitoring: 25.2.1. seek to identify and record any indirect, delayed and/or cumulative adverse effects that have not been designed for risk assessment; 25.2.2. uses a longer period of time and most of the area; 25.3. General monitoring, including the location, area and all measured parameters, largely depends on what unexpected adverse effects. For example, to monitor the unintended adverse effects on the ecosystem of cultivated as changes in bio-diversity, distribution, and interaction of multiple cumulative environmental effects, it may be necessary for other general monitoring method to monitor other gene transfer; 25.4. the General compatibility of monitoring may be used for the periodic monitoring of traditional practices, such as agricultural crops, plant protection products, veterinary and medical monitoring, as well as ecological monitoring, environmental monitoring and conservation programs. The monitoring plan may also include details of how the permissions the recipient obtains the relevant information gathered by the third parties of the traditional practice of periodic monitoring or as this information is available to the recipient of the permit; 25.5. If the overall monitoring used in traditional periodic monitoring, describes both the practices and the changes that it needed to make the overall monitoring.
26. The baseline: 26.1. receiving environment the baseline condition is a prerequisite for monitoring the change observed for identification and evaluation. The base line is a point of reference with which to compare any effects caused by genetically modified organisms distribution market. Therefore, the baseline is determined before attempting to detect and monitor any impact. Parallel the areas of genetically modified organisms and the comparable area where no genetically modified organisms, monitoring may be an alternative, and it can play a role, if the environment is particularly dynamic; 26.2. reliable information about the condition of the receiving environment, based on adequate environmental monitoring systems, may be required before the monitoring programme and environmental policy measures. Environment observation programmes are designed to take into account the proven, probable or possible ecosystem relationships, and you can bet to determine: 26.2.1. State of the environment and changes therein; 26.2.2. the causes of such changes; 26.2.3. upcoming environmental development; 26.3. the receiving State examples of indicators can include animals, plants and micro-organisms from different groups of organisms and ecosystems. Relevant indicators may be considered based on genetically modified organisms and the characteristics of the monitored parameters. In this sense, the meaning can also be other organisms ability to intersect with genetically modified organisms. The indikatorsug has several possible measurement parameters or fitness variables, including the number, growth rate, biomass, reproduction, population increase/decrease the speed and diversity of genetic similarity; 26.4. it is also appropriate to consider the baseline ratio of changes management practice that determines the use of genetically modified organisms. These can include changes in the use of pesticides in cereals cultivation of plant species, modified herbicide-resistance and resistance to insects. It is also appropriate to consider the monitoring plan crops genetically modified to be herbicide-resistance, herbicide usage be considered conventional crops, adopted on the basis of the line component.
period: 27 27.1. monitoring shall be carried out in the period which is sufficiently long to detect not only to the probable immediate impact but also the late impacts that are identified in the risk assessment. Also consider the relationship between the estimated level of risk and the duration of the release. Longer period of proliferation may increase the risk of cumulative effects. If the longer period gets immediate effects, monitoring can then focus on late and indirect impacts. Also consider whether the monitoring plan shall apply for a period that is after the agreed period. It can be, for example, if genetically modified organisms are particularly persistent in the environment; 27.2. indicates the intended period of the monitoring plan, including an outline of the possible frequency of inspection and monitoring plan review interval. Take into account the impact of any such expression, outlined in the risk assessment. For example, consider any adverse effects arising from the release of genetically modified organisms, reproduction and persistence/survival environment after distribution market. Genetically modified microbes, which is distributed in accordance with biological treatment programs, this time may be days or months, but some of the crop species, it could be several years. The same modification order and the possibility of considering durability also to inbreeding with sexually compatible species; 27.3. inspection planning is largely dependent on the type of impact monitored. For example, the impact caused by pollen transfer, gets just after flowering, but are useful sites to visit before flowering to establish what is the compatible species presence. Likewise, the emergence of volunteer plants in subsequent periods of growth monitoring in relation to the time of seed cultivation and subsequent seed bank persistence and germination;
27.4. previous visits are also required before the start of the monitoring to determine the base line; 17.1. the monitoring plan periods should not be unlimited in time, but it will be reviewed and amended in accordance with the results obtained in implementing the monitoring programme.
28. The allocation of responsibilities: 28.1. in accordance with the rules final responsibility for the inclusion in the application of the monitoring plan, design and proper execution is the applicant/consent holder; 28.2. the genetically modified organisms in the distribution market, the applicants submissions include a monitoring plan in accordance with Chapter VI. The adequacy of the monitoring plan provided is one of the criteria by which to judge any application of genetically modified organisms on the market. Judging for the plan, only based on whether it is sufficient for the fulfilment of requirements set out in these regulations, and that it is close in accordance with this annex; 28.3. the distribution of a product containing or consisting of those submissions, the notifier shall ensure that monitoring and reporting in accordance with the conditions specified in the permit. This is achieved, the implementation of the monitoring plan; 28.4. the application in each stage of the monitoring plan should clearly define responsibilities. This applies both to specific monitoring and overall monitoring, which is part of the monitoring plan. The applicant will bear the responsibility for the implementation of the monitoring, but this does not preclude third parties such as consultants and user involvement, monitoring of execution of different tasks required by the monitoring plan. The General may be involved in the monitoring of the Member States of the European Union, the Commission, the Member States and/or the competent authorities. Employing third person or latch with them on contract to conduct monitoring studies, their involvement in the scheme in detail. The applicant/holder is responsible for the collection of monitoring data and results, and provides this information to the Member States of the European Union, transmitted to the Commission and the competent authorities in accordance with the monitoring plan, especially with regard to the harmful effects of any identification; 28.5. you can perform additional monitoring, which can be either a specific monitoring specific cases or general monitoring. The purpose of such monitoring are given risk manager the opportunity to immediately take appropriate measures if a previous risk assessment results in unwanted or unidentified. However, such action is not a substitute for the monitoring plan (although, with the consent of the persons concerned may be a part of it), the implementation of which liability reserves the applicant.
29. the existing system: 29.1. it is possible to extend existing monitoring or General the monitoring system, the potential adverse effects arising from the release of genetically modified organisms. These systems include observation programmes in agriculture, food surveys, nature conservation, long-term ecological monitoring system, environment observation programmes and veterinary studies; 29.2. for example, seed production systems which comply with the OECD OECD certification rules and so the field and the periodic inspection of the area, you can adjust the specified monitoring on the field; 29.3. the regular monitoring of the Member States komerckultūr on fertilizer and pest, calculation of disease and weed control. This type of monitoring during the entire growing period regularly carried out advisers who sell agricultural products concerned, and growers; 29.4. sale of genetically modified seeds can be supplemented with similar service in which companies representatives or hired consultants at least some form of overall monitoring. Instructions relating to the monitoring and reporting, can be distributed to growers purchasing genetically modified seeds, and treaty rules can formulate sales or conditions of use; 29.5. where there is clear instructions, growers and agricultural consultants can explore a major unexpected changes or impacts to the volunteer and the introduction of plant propagation, growing in adjacent areas. In these circumstances it is expected that the monitoring of adverse effects can include periodic practice used to determine agricultural inputs pest and weed control.
30. the Monitoring methodology.
This section provides guidance on those parameters and elements that can be identified and which you may include monitoring the monitoring program, as well as the means for carrying out such monitoring, including the monitoring areas and on the frequency of monitoring.
31. the Monitoring parameters/elements: 31.1. Firstly, identify the relevant effects parameters/elements, giving it the designation. It depends largely on the conclusions of the risk assessment. Decisions on the monitored parameters or elements adopted individually in each case according to the genetically modified organism in the changed characteristics. They include monitoring the suitability of the intended effects on the target organisms, modified such as the corn borer population monitoring in relation to the cultivation of Bt maize varieties; 31.2. the components of the monitoring plan may also consider such elements that are not specific, and the element, not excluding other include: 31.2.1. effects on non target organisms, organisms and resulting from the modification, including development of resistance in wild relatives or pest organisms, change in the host range or pest organisms and viruses, as well as distribution of new viruses; 31.2.2. dispersal, establishment and persistence in the environment or ecosystems that are not the target environment or ecosystems; 31.2.3. the intersection/breeding (e.g., intersection/breeding frequency, type and intensity), with sexually compatible wild relatives in natural populations of organisms; 31.2.4. unforeseen changes in the basic of the organism, for example, changes in the number of offspring in reproduction, growth, and survival of the seed; 31.2.5. changes in bio-diversity (for example, the number of species or composition).
32. The area/samples: 32.1. the monitoring plan may include details as to where and how the monitoring will be carried out in the area. You can specify the individual Member States, geographic region, territory, land or other area where appropriate; 32.2. identifies the areas to be monitored and/or samples relating to the possible effects caused by genetically modified organisms on the market, including those intended for a report or control. All reports or control areas and/or samples must be sufficiently representative of the environment and conditions of use, to get meaningful conclusions. In addition, the entire sampling methodology should be scientifically and statistically sound. Of the following sound data can be obtained important information on changes in the index, and it increases impact detection; 32.3. in considering the areas monitored, for example, in the case of genetically modified crop species, determining the habitats chosen for monitoring, this species may be considered signs (intrinsic and modified), as well as its reproduction and dissemination, and ecosystem types that you can influence. At monitoring major areas include designated agricultural fields where crops are grown commercially, and surrounding habitats; 32.4. the monitoring can also be extended to adjacent or neighbouring cultivated and non-cultivated areas as well as areas after harvest monitor volunteer plants and protected areas. Some types of habitats, for example, disturbed areas, and species-rich plant communities are more susceptible to infestation than others. Disturbed areas with low vegetation and an abundance of plants and grasses, are particularly suitable for monitoring purposes. First, they are widespread and often close to more intensive agricultural areas cultivated. Secondly, these areas are often typical of roadsides, ditches and edges of fields, which in the beginning most often occurs accidentally in the loss and dispersion of seeds; 32.5. the monitoring may also be considered in relation to the possibility of transfer of genetic material to sexually compatible organic and conventional crops. To this end, shall assess the extent to which such crops grown in adjacent or neighbouring areas.
33. The inspection.
The monitoring plan shall specify the expected frequency of inspection. You can include a graphic that shows the area and number of visits. In this respect, as set out in the preceding paragraphs, well considering that during the possible adverse effects and likely gets the (s) area (s) to be monitored.
34. sampling and analysis: 34.1. also these parameters/elements of the methodology for further monitoring, including sampling and analysis techniques, clearly identified and set out. If the standard is applicable to the methodology set out in the standards, the price and the OECD (OECD) methods for monitoring organisms in the environment, then they follow and indicates the source of the methodology. Methods used for monitoring should be scientifically sound and valid experimental conditions in which they are used; Therefore, consideration should be given to the characteristics of the methods, such as selectivity, specificity, reproducibility, any limitation in sensitivity, as well as the availability of appropriate controls; 21.3. the monitoring plan shall also indicate the anticipated updating of the methodology, if necessary, in accordance with the monitoring method/strategy; 21.3. in designing the appropriate sampling and analysis methodology can also be used for statistical analysis to determine optimal sample sizes and shorter periods of monitoring the effects of opening with the necessary statistical accuracy.
35. Data collection and processing: 21.8. monitoring plan for specific monitoring and overall monitoring, specify how and how often, to collect and process the data. This is especially important if the data collection employs or hires a third party. The applicant must have the standard mechanisms, formats and protocols for data collection and tracking to ensure consistency. For example, standardized registration pages or direct recording with portable computers to a standardised spreadsheet. The applicant will also outline how the data are processed, and receives information from third parties, such as consultants or users; 35.2. also indicate dates and intervals for reporting monitoring results.
36. Analysis, reporting, review.
The monitoring plan shall specify how often data for the report and made it a general analysis.
37. evaluation: 37.1. as needed in the evaluation of the data included in the statistical analysis with the relevant standard deviation values, so you can make informed future decisions. These include decisions about whether the ratings outlined in the risk assessment are correct. In this respect, the correctness of the assessment to a large extent on how correct is the base line and/or control relating to the receiving environment. Statistical analysis gives information on whether the methodology, including sampling and analysis has been applied; 37.2. monitoring and evaluating the results of the studies can determine whether you need to monitor the other parameters that are in accordance with the program. Also check the appropriate response to any previous conclusions, especially when there is evidence of possible undesirable effects on the Habitat and organisms susceptible groups. 37.3. the monitoring data collected through the interpreted under other existing environmental conditions and activities. If changes in the environment are observed, further assessment is needed to determine whether they are genetically modified organisms or the use thereof, or the effect of such changes are caused by such environmental factors, which are not genetically modified organisms on the market. Repeating the base line, which is used for comparison in this respect; 23.2. the design of the monitoring plan are such that special monitoring in certain cases, the general monitoring and additional research results clearly can be used to make decisions about the renewal of the product distribution.
38. reporting: 38.1. after the dissemination of genetically modified organisms on the market of the applicant in accordance with these rules is necessary to ensure the monitoring and reporting in accordance with the conditions specified in the permit. Reports on the monitoring of the Member States of the European Union, submitted to the Commission and to the competent authorities of the Member States, although the deadline is set. This information is also available to the public in accordance with the requirements of this regulation. Therefore, the application the applicants conditions of reporting describe the monitoring plan; 38.2. the monitoring plan also determines how authorisation to the consignee and to the competent authorities in the relevant delivery information collected within or periodic monitoring in practice; 38.3. the applicant/consent holder shall ensure the transparency of the results and monitoring programmes and monitoring of the measures plans will govern how information collected is submitted/published. It can, for example, be achieved by: 38.3.1. with information pages for users and other interested parties; 38.3.2. with seminars that present and exchange information with stakeholders; 38.3.3. archived internal documents of the company; 38.3.4. including information company websites; 38.3.5. public information and scientific publications; 23.9. subject to the reporting provisions that the applicant shall immediately take the measures necessary to protect human health and the environment, and inform the competent authorities if the users or other sources, the availability of new information relating to the risk; 38.5. the applicant in the review information and conditions specified in the application.
39. the review and adaptation: 24.3. monitoring plans should not be regarded as static. It is essential to the monitoring plan and the related methodology to review at the intervals and if necessary to update and adapt; 24.4. in accordance with the rules of the competent authority that receives the original of the application, on the basis of the reports provided by the applicant, and subject to the authorization and the specified monitoring plan is authorized to adapt the monitoring plan after the first monitoring period. However, also on the revised monitoring plan answers the applicant; 39.3. the review of the test data collection and measurement, including sampling and analysis of efficiency and quality. The review shall also assess the effectiveness of the monitoring criteria for ratings, and shall examine all issues arising from the risk assessment; 24.5. If forecasting, for example, uses special models, then you can make an assessment based on the data collected, and subsequent appraisal. Also takes into account as appropriate the sampling and analysis methods for innovation and development; 39.5. after such review is required, the methods of monitoring and the objectives of the monitoring programme for the adaptation or improvement.
Health Minister r. Muciņš