The Rules On Genetically Modified Organisms Deliberate Release

Original Language Title: Noteikumi par ģenētiski modificēto organismu apzinātu izplatīšanu

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Cabinet of Ministers Regulations No. 457, Riga, 26 May 2009 (pr. No 33 47) rules on procedures for genetically modified organisms released into the environment or market monitoring and authorisation procedures, as well as the arrangements for providing information on the movement of genetically modified organisms, and public involvement in the decision-making process in accordance with the movement of genetically modified organisms Act 5 of the first paragraph of article 2, paragraph 1. General questions 1. determines: 1.1. procedures for genetically modified organisms released into the environment or market; 1.2. monitoring and authorisation procedures;
1.3. procedure for providing information on the movement of genetically modified organisms;
1.4. public involvement in the decision-making process. 2. the rules shall not apply to: 2.1 the genetically modified organisms for limited use;
2.2. genetically modified food and animal feed distribution market, to which the European Parliament and of the Council of 22 September 2003 Regulation (EC) No 1829/2003 on genetically modified food and feed;
2.3. the medicinal products containing genetically modified organisms, composed or derived from them, the environment or the distribution of medicinal products on the market, except for the risk assessment of medicinal products in accordance with the provisions of paragraphs 16 and 17;
2.4. the genetically modified organisms for transport by road, rail, inland waterway, sea or air. 3. genetically modified organisms Before distribution commences in accordance with the legislation on genetically modified organisms for the risk assessment, a risk assessment methodology to identify genetically modified organisms in particular the possible impact on human and animal health or the environment, which are genetically modified organisms will be distributed. 4. to receive the food and veterinary service (hereinafter service) written permission to distribute or market environment, genetically modified organisms, the person: 4.1 payment of State fee in accordance with the legislation on genetically modified organisms for the risk assessment of the preparation of the opinion of the State fee;
4.2. service fees national identity document or a copy of it and the application that is designed according to the provisions of Chapter 7. 5. Service not later than three working days after receipt of the application, checks the compliance with this provision, 54, and forward it to the Scientific Commission of experts, as well as the rules referred to in section 5 in the order, inform the public. 6. If the application does not comply with this rule 54. point or in accordance with the documents it is not possible to fully carry out a risk assessment, appropriate reasons, may require the person to submit additional information or perform additional consultations, including with the public. Additional information or consultation required time excluded this provision 9, 20, 27 and 39 within the paragraph. 7. the Department, in consultation with the parties, shall decide on limited access status for a specific information contained in the application on the basis of the freedom of Information Act, and shall not disclose this information to a third party. 8. the limited availability of information does not consider the following: 8.1 the personal name, address (legal person – name and legal address);
8.2. Description of the genetically modified organism that allows it to be identified;
8.3. the genetically modified organisms for the purpose of distribution, location, and expected usage;
8.4. the monitoring programme and emergency plans;
8.5. the genetically modified organisms for the risk assessment. 9. the Scientific Commission of experts not later than 60 days after receipt of the application, shall prepare and transmit to the Department in particular genetically modified organisms present Orga risk assessment opinion on environmental risk assessment and other information contained in the gum cold (hereinafter referred to as the risk assessment opinion). 10. the Scientific Commission of experts not later than five working days, drawing up an opinion on the public expressed the views and proposals submitted (hereinafter referred to as the opinion on public opinion). Service to identify public opinion, may extend this provision 20, 27 and 39, paragraph for a period of time not longer than 30 days. 11. Service not later than one working day after the risk assessment and the opinion of the public opinion views the receipt sent to the genetically modified organisms to the Supervisory Board. 12. the genetically modified organisms for the Supervisory Board not later than 15 working days after the opinion of the risk assessment and the opinion of the public views received in the service of the submitted proposals for authorisation of genetically modified organisms in particular distribution environment or market. 13. the service, having regard to the opinion of the risk assessment, opinion on public opinion and genetically modified organisms, the proposal of the Supervisory Board shall issue a written decision on the permit or refusal to issue a permit, specifying the grounds for refusal. 14. If you change the use of the genetically modified organism, the person for the purpose of service of the new application shall be submitted. 15. If during the examination of the application or after the authorization of the person new information has become available or if genetically modified organisms or their components have changed in a way that may cause adverse effects on human and animal health or the environment, a person: 15.1. take measures to protect human and animal health or the environment; 15.2. inform service and national environment about the genetically modified organisms or their components;
15.3. the report of the activities specified in the application. 16. the medicinal products containing genetically modified organisms or composed or derived from those used in the clinical trial according to the regulations on the procedure for the conduct of clinical trials and procedures are evaluated compliance with good clinical practice requirements. 17. Service not later than 90 days after receipt of the application for the use of the clinical trial, which contain genetically modified organisms or composed or derived from them, shall send to the person who submitted the application, risk assessment opinion. 2. the issue of the genetically modified organisms into the environment 18. If the same genetically modified organism, or the same combination of genetically modified organisms in the distribution environment for different locations, but with the same purpose and within the specified period, the person may submit one application in the service. 19. the Department no later than 30 days after receipt of the application submitted to the Commission of these provisions referred to 54.6. summary. 20. the service no later than 90 days after receipt of the application and the competent authorities of the other Member States in the evaluation of the proposals submitted, if any, of the decision referred to in paragraph 13 of the rules of procedure. 21. the authorisation shall specify: 21.1. environment distributed the genetically modified organism identity;
21.2. the conditions for the distribution of genetically modified organism into the environment;
21.3. the monitoring requirements, including monitoring of program deadlines. 22. the service shall be submitted to the European Commission a reasoned proposal for the application of the different procedures for granting authorization, if sufficient experience has been obtained for a particular distribution of the genetically modified organism into the environment and that meet the following criteria: 22.1. There is some non-genetically modified (recipient) organism's taxonomic affiliation and biology (such as reproduction and pollination, ability to cross way with related species, pathogenecity);
22.2. There are reasonable information that non-genetically modified (recipient) organism or, where appropriate, the parental organisms in the distribution environment, the ecosystem in question does not cause adverse effects on human and animal health or the environment; 22.3. information is available on the major interactions involving non-genetically modified (recipient) organism, in appropriate cases, parents and other organisms in the ecosystem in the body;
22.4. the expected distribution environment type using genetically modified organism distribution methods that are analogous to those of genetically modified organisms, the use of which has already been authorised, and the results obtained show that there is no harmful effect on human and animal health or the environment; 22.5. complete information is available on vektorsistēm and the genetic structure of the insert and you can use it for genetically modified organisms and their descendants to identify as well as the deletion mutation is known, if the genetic modification is related to the deletion mutation of genetic material;

22.6. the genetically modified organisms does not cause more adverse effects on human and animal health or the environment, compared to the corresponding non-genetically modified (recipient) organism or, where appropriate, the parental organisms. The ability to spread unchecked environment, take over other non-familial ecosystem and to transfer genetic material to other organisms in the environment do not cause adverse effects on human and animal health or the environment. 23. According to the European Commission decision on different procedures apply to the consent given in accordance with European Union legislation on European procedures for the exercise of implementing powers conferred on the service within three working days, issue the person a written permission or a reasoned decision to refuse to issue the permit. 24. If the Department receives information about the environment of the genetically modified organism in disseminated would cause adverse effects on human and animal health or the environment, after consulting with the national environmental service: 24.1. require a person to change the conditions for distribution in the environment;
24.2. suspended for or prohibits the release into the environment;
24.3. inform the public about the decision taken. 3. the authorisation of genetically modified organisms in the distribution market 25. a Person who wants to start the distribution of genetically modified organisms on the market, for which the European Union is not authorised, in addition to the application of this provision in paragraph 54, the information includes: 25.1. information in accordance with the provisions of Chapter 8. The person drawing based on the results obtained at a time when genetically modified organisms are distributed in the environment, or in the light of scientific information, which shows that the proliferation of genetically modified organisms and the use of the market do not pose a risk to human and animal health or the environment, shall have the right to ask the permission of the service does not include this provision in the application the information referred to in paragraph 70;
25.2. the conditions of genetically modified organisms in the distribution market, including specific conditions of use and storage;
25.3. the anticipated duration of the authorization;
25.4. the monitoring program pursuant to Chapter 9 of these rules, including proposals for monitoring the implementation of the programme;
25.5. the proposals for labelling and packaging requirements specified in Chapter 8 of these regulations and of the European Parliament and of the Council of 22 September 2003 Regulation (EC) no 1830/2003 concerning the traceability and labelling of genetically modified organisms, as well as produced from genetically modified organisms of the traceability of food and feed products and amending Directive 2001/18/EC;
6. data or results of a specific genetically modified organism, or the same combination of genetically modified organisms, if it has been notified in advance to one of the competent institutions of the Member States, or notified to the given moment or if a particular genetically modified organism is distributed in a Member State of the European Union or outside it. 26. If the application contains all the rules in the information referred to in paragraph 25, the service no later than three working days, send to the rule referred to 54.6. summary the European Commission and the other competent authorities of the Member States. 27. the Department not later than 90 days after receipt of the application, send a risk assessment opinion: 27.1. the person that made the application;
27.2. the European Commission. 28. in addition to these terms of service. information referred to in paragraph 27 to send the information to the European Commission, on the basis of which proposes to issue specific authorizations of genetically modified organisms in the distribution market, or the information on the basis of which proposes not to issue specific authorizations of genetically modified organisms in the distribution market, – not earlier than 15 days after the transmission of the opinion of the risk assessment to the person, and no later than 105 days after receipt of the application. 29. in the opinion of the Risk assessment apply to genetically MODI ficēt organisms, intended use and the proposed monitoring program. Risk assessment opinion stating: 29.1. conditions under which a particular genetically modified organism may or may not be distributed on the market. If the risk assessment shows that the specific opinion of genetically modified organism cannot distribute market service provides a reasoned justification;
29.2. non-genetically modified (recipient) organism characteristics that apply to a particular genetically modified organism risk assessment, as well as potential adverse effects on human and animal health or the environment may cause non-genetically modified (recipient) organism distribution environment;
29.3. the genetically modified organisms in genetic modification;
29.4. the assessment of whether the genetic modification has been characterised sufficiently for the identified potential adverse effects on human and animal health or the environment;
29.5. in accordance with the environmental risk assessment to identify new potential harmful effects on human and animal health or the environment, which can lead to certain genetically modified organisms in the distribution market. Potential adverse effects are determined by comparing the genetically modified organisms with the corresponding non-modified organism;
29.6. specific environmental risk assessment questions that are asked by the European Commission and the competent authorities of the other Member States. 30. When the person, after receiving the opinion of the risk assessment reference application, it can submit a repeated application to the competent institution of another Member State. 31. If the scientific experts, the Commission has prepared an opinion on risk assessment, showing that the genetically modified organisms can be distributed on the market, and not later than 60 days following the dispatch of the opinion of the risk assessment in the absence of reasoned objections from the European Commission and from other Member States or the competent Thai authorities on the complaints received have reached 105 days after the transmission of the opinion of the risk assessment, the Department shall issue to the person a written authorisation of genetically modified organisms in the distribution market. 32. If the Commission or a Member State of the European Union, the competent institution shall make and maintain an objection in accordance with the provisions of paragraph 31 and 36, the decision is taken in accordance with European Union legislation on European procedures for the exercise of implementing powers conferred on the. 33. The European Commission shall take a decision on the authorisation of service no later than three working days after the date of adoption of this decision shall be issued to the person the written authorisation of genetically modified organisms in the distribution market. 34. the genetically modified organisms Authorised for distribution in the market be issued for a period specified in the application, but not more than 10 years. 35. the authorisation shall specify: 21.8. the scope of the authorisation is to be applied, as well as the market of the genetically modified organism distributed identity and unique identifier;
35.2. the period of validity of the authorisation;
35.3. the conditions of genetically modified organisms in the distribution market, including specific genetically modified organism, processing and packaging, as well as the specific requirements of the environment, the ecosystem and geographical area protection conditions;
35.4. the availability of service controls, provides the corresponding konfiden cialitāt requirements;
22.1. the labelling requirements in accordance with Chapter 8 of these rules;
35.6. the monitoring requirements according to this provision, as well as Chapter 9:35.6.1. monitoring programme deadlines;
35.6.2. special instructions (if any) genetically modified organisms or users and sellers of genetically modified crops growers;
35.6.3. If growing GMOs crops organisms – other information necessary for the particular place of production. 36. If the service received information about market distributed genetically Modifi Ed organisms resulting in adverse effects on human and animal health or the environment: 36.1. written authorization before it no later than three working days shall forward this information to the European Commission and the other Member States the competent Thai authorities. Service can discuss unresolved issues with the European Union Member States competent authorities, to 75 days before the issue of a written agreement;

36.2. the written authorisation, it not later than 60 days shall be forwarded to the European Commission proposal on changing the conditions of authorization (if required). If, within 60 days after the sending of a reasoned objection has been received or 75 days after shipping has been agreed for the objections expressed by service shall decide on the conditions of the authorization, shall notify the person and, within 30 days after the adoption of the decision shall inform the European Commission and the competent authorities of the other Member States. 37. the launching of genetically modified crops, after the service of written authorisation ensures coexistence between genetically modified crops and the specific requirements in accordance with the laws and regulations on coexistence, as well as the monitoring and control procedures. 4. extension of authorisation for genetically modified organisms in the distribution market 38. To extend the authorisation of genetically modified organisms in the distribution market, the person is at least nine months before the expiry date of the authorisation submitted to the service (if first-time permission is provided by service) application. The application shall be accompanied by: 38.1. first licence or a copy thereof;
38.2. in accordance with the submitted monitoring programme to prepare a report on the results of monitoring during the preceding release;
23.8. any other information that is available and relevant to the genetically modified organisms for potential harmful effects on human and animal health or the environment; 23.9. first amendment of or addition permit conditions (if provided), as well as the conditions relating to the subsequent monitoring and authorisation period. 39. If the application complies with the provisions of paragraph 38, service no later than 90 days after receipt of the application, sends the opinion of the risk assessment to the person who submitted the application and shall forward the application or a copy of the risk assessment and the opinion of the European Commission, stating that: 39.1. the genetically modified organisms can continue to distribute market and distribution conditions;
24.4. the genetically modified organisms in the distribution market is discontinuing. 40. If the scientific experts the Commission has prepared an opinion on risk assessment, showing that genetically modified organisms may continue to spread in the market, and not later than 60 days after the sending of the opinion of the risk assessment from the European Commission and from other Member States ' competent authorities have received reasoned objections or 75 days after the opinion of the risk assessment for transmission of the objections received in the agreed services no later than three working days, issue the person a written permission for further dissemination of genetically modified organisms on the market. 41. If the Commission or a Member State of the European Union, the competent institution shall make and maintain objections, the decision is taken in accordance with European Union legislation on European procedures for the exercise of implementing powers conferred on the. 42. The European Commission shall take a decision on the authorisation of service no later than three working days after the date of adoption of this decision shall be issued to the person a written permission for further dissemination of genetically modified organisms on the market. 43. Extended permission for genetically modified organisms in the distribution market is issued for up to 10 years. 44. If a first-time permits have not expired, a person to extend authorisation to continue the proliferation of genetically modified organisms on the market under the conditions specified in the first authorization. 5. Public participation in the decision-making process in its 45. Service website puts the State in the information system – the movement of genetically modified organisms in the register (hereinafter register), the following information: 45.1. not later than three working days after receipt of the application: 54.5. these provisions 45.1.1. referred to the environmental risk assessment;
45.1.2. This provision 54.6. Summary of the information referred to in point a;
45.1.3. rest of the documents presented, which does not have a restricted availability status;
45.2. not later than three working days after receipt of the opinion of the risk assessment: 45.2.1. risk assessment opinion.
45.2.2. time limits by which the public can express their views and make suggestions, indicating their submission;
45.3. not later than three working days after the adoption of the decision: decision 45.3.1. including the conditions referred to in the authorisation in accordance with the provisions of article 21 and 35 and about public opinion;
45.3.2. information about genetically modified organisms in the environment;
45.3.3. information on the cultivation of genetically modified organisms;
28.2. no later than three working days after receipt of the report – a report on the distribution medium or market monitoring results. 46. any person within 30 days after the opinion of the risk assessment into the registry, you can express your opinion and to submit written proposals to the Department of the dissemination of genetically modified organism into the environment or the market. 47. If the received information about the environment, or distributed on the market of genetically modified organisms would cause adverse effects on human and animal health or the environment, or for the non-authorised genetically modified organism distribution market, the service will inform the company, within one day of receipt of the information by inserting information service website, by publishing it in a newspaper "journal" and the administrative area or locality, as well as a newspaper announcing on television and radio. 6. Duties and rights 48. Service not later than three working days after submission of the genetically modified organism release into the environment or market receipts shall inform the Ministry of agriculture, the national environmental authorities and local authorities, in the territory of which the intended dissemination of genetically modified organisms into the environment or the market. 49. the service every three years to draw up and submit to the European Commission report on the measures taken in implementation of those rules. The report includes a brief overview of experience gained working with genetically modified organisms in the distribution market, according to these rules. 50. If the risk to human and animal health or the environment, the Department makes a decision to ban a genetically modified organism distribution market or determine its limits and send the relevant information to the European Commission and other competent authorities of the Member States. Information about the decision whether and how it would be amenable to permit distribution in market conditions or market distribution prohibited. Service in addition to submit a reasoned opinion indicating the latest scientific knowledge, to which the decision is based, and for making the decision shall inform the public. 51. the service within 30 days after the competent authorities of another Member State in application of the posted summary of genetically modified organisms into the environment shall prepare a reasoned objection or proposal and submit it directly to the competent institution of a Member State or the European Commission. Service may ask the competent authorities of the Member State concerned shall send a copy of all submissions or, if this is necessary for the proposal or argument. 52. the service within a period of 60 days after the competent authorities of other Member States in the risk assessment of posted an opinion on genetically modified organisms in the distribution market, prepare a proposal or reasoned objections and submit it directly to the competent institution of a Member State or the European Commission. Service may ask the competent authorities of the Member State concerned shall send a copy of all submissions or, if this is necessary for the proposal or argument. 53. the service shall be submitted to the European Commission: 53.1. within 30 days after the issue of the permit – information on the decision taken on the distribution of genetically modified organisms in the environment (if permission was issued, giving reasoned views);
53.2. within 30 days after the issue of the permit – information on the decision taken on genetically modified organisms on the market (if permission was issued, giving reasoned views), as well as inform the other competent authorities of the Member States;
53.3. information about genetically modified organisms in the environment and market monitoring results;
53.4. once a year, the list of issued permits and genetically modified organisms into the environment according to the rules referred to in point 22 different procedure;
13. no later than three working days – information about the non-authorised genetically modified organism distribution market, and shall inform the competent institution of the other Member States. 7. the information to be included in the application of genetically modified organisms into the environment or the market application on 54. genetically modified organisms into the environment or market a person include the following information: 54.1. name, surname, address (legal person – name and legal address);
54.2. the responsible scientist name, qualifications and work experience;
54.3. application name;
54.4. information in accordance with the provisions of subsection 7.2 or 7.1;

54.5. genetically modified organisms, the environmental risk assessment carried out according to the laws and regulations on genetically modified organisms for the risk assessment methodology;
54.6. a summary of the information according to the rules referred to in annex 1, if genetically modified organisms will be distributed in the environment, or in accordance with the rules in Appendix 2 of these requirements, if genetically modified organisms will be distributed on the market;
54.7. other information related to a particular genetically modified organism and that the person considers relevant or reference to information previously published by other people, if not limited availability information, or that the person has given its written consent to such use. 55. the application may not include all of these provisions 7.1. and 7.2. information referred to in sections below. Accordance with the contents of the application, taking into account the specific characteristics of each case. 56. This provision relates to subsection 7.1 all types of genetically modified organisms, genetically modified other than higher plants (higher plants), release into the environment or the market. 57. These rules apply to subchapter 7.2 higher plants release into the environment or the market. 58. the higher plants within the meaning of this provision is a plant belonging to the flowering plant (angiospermae) and kailsēkļ (gymnospermae) taxonomic groups. 7.1. the information to be included in the application of genetically modified organisms (other than higher plants) release into the environment or market 59. information about genetically modified organisms: 59.1. the donor, recipient or (where appropriate) parental organism of the article rojum: 59.1.1. scientific name;
59.1.2. taxonomic affiliation;
59.1.3. other names (for example, the common name, the name of the variety);
59.1.4. phenotypic and genetic characteristics;
59.1.5. the donor and recipient of the degree of relationship or the degree of relationship with the parental organisms;
59.1.6. methods of determination;
59.1.7. detection and identification methods for sensitivity, reliability (in the tatīv quantum sense) and specificity;
59.1.8. geographical distribution and of the natural environment (including information about natural enemies, objects, parasites and competitors, symbionts and hosts);
59.1.9. organisms with which natural conditions is possible transfer of genetic material;
59.1.10. genetic stability and factors affecting it;
59.1.11. pathological, ecological and physiological traits: 59.1.11.1. hazard classification;
59.1.11.2. life expectancy in natural ecosystems, sexual and bezdzimumvairošan cycle;
59.1.11.3. information on survival, including adaptation to climate change and the ability to form survival structures under adverse environmental conditions, such as seeds, spores, sclerotia;
59.1.11.4. pathogenicity: infection, toxicity, virulence, allergenicity, carrier of pathogens (vector), possible vectors, host range including the optional host. Latent virus (provirus) possible activation. Ability to colonise other organisms;
59.1.11.5. antibiotic resistance and may use this antibiotic in people and in the prevention and treatment of domestic animals;
59.1.11.6. participation in environmental processes, such as primary production, nutrient circulation, decomposition of organic substances in the process, breathing;
59.1.12. building a vector used in the specification: 59.1.12.1. sequence;
59.1.12.2. frequency of mobilisation;
59.1.12.3. specific features;
59.1.12.4. antibiotics and other resistance genes;
59.1.13. information on the genetic modification of previously made;
59.2. the vector characteristics: 59.2.1. Vector structure and origin;
59.2.2. transposable, vector and other fragments of the genetic sequence information, used to a particular organism genetically modified new created in the heredity material;
59.2.3. vector used in the genetic frequency of mobilisation or genetic transfer capabilities and methods of determination;
59.2.4. information about the function, the required minimum vector DNA (DNA) of the structure;
59.3. Description: 59.3.1. Description of the genetic modification: 59.3.1.1. the genetic modification methods used;
59.3.1.2. methods used to create and deliver the recipient inserts or induced DNA nucleotide sequence deletion;
59.3.1.3. the insert or the vector construction;
59.3.1.4. unknown sequence option inserts the presence of structure and information about the function, the required minimum vector DNA structure;
59.3.1.5. favorite methods and criteria used;
59.3.1.6. particular modified, inserted, or removed the fragment of nucleic acid sequence, functional identity and location in the genome, especially in connection with genetically modified organisms for any potential hazards;
59.3.2. for genetically modified organism in the description: 59.3.2.1. genetic traits or phenotypic traits, notably new traits and traits that are genetically modified or in the body can take that expression is not possible;
59.3.2.2. any vector or donor nucleic acid structure and quantity of genetically modified organism remains the final genome;
59.3.2.3. genetic stability of the organism;
59.3.2.4. the new genetic material expression intensity and level. Measurement method and sensitivity;
59.3.2.5. protein synthesised (protein) activity;
isolation and identification of 59.3.2.6. a description of the methods, including techniques for the identification of the insert and vector and isolation;
59.3.2.7. methods of isolation and identification sensitivity, reliability (in quantitative sense) and specificity;
59.3.2.8. information on genetically modified organisms, the previous release or use.
59.3.2.9. health-related considerations: inanimate 59.3.2.9.1. genetically modified organisms or their metabolic products toxic and allergenic effects;
59.3.2.9.2. the genetically modified organism, the comparison to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;
59.3.2.9.3. the colonization of ability;
59.3.2.10. If the organism is pathogenic to humans who are immunocompetent:. izraisām 59.3.2.10.1 diseases and pathogenic mechanisms, including invazivitāt and virulence;
59.3.2.10.2. infectivity;
59.3.2.10.3. infective dose;
59.3.2.10.4. host range and change;
59.3.2.10.5. the possibility of survival outside of human body;
59.3.2.10.6. the presence of vectors or the uncontrolled spread of options;
59.3.2.10.7. biological stability;
59.3.2.10.8. antibiotic resistance spectrum;
59.3.2.10.9. the allergenicity;
59.3.2.10.10. availability of appropriate treatment methods;
59.3.2.11. other risks associated with genetically modified organisms. 60. Genetically modified organisms in the environment or market conditions and environment: information on the distribution of 60.1.: 60.1.1. for a description of the distribution, its objectives and the products to be acquired;
60.1.2. the envisaged date for the distribution and dissemination in the environment for some time, including the frequency and duration of the release;
60.1.3. the site of the original preparation;
60.1.4. the size of the release site;
60.1.5. methods used in the distribution;
60.1.6. distributable quantity of genetically modified organisms;
60.1.7. proposed changes in the site (type and method of processing, modification of the composition of soil, irrigation, or other activities);
60.1.8. at the time of the distribution to do protection measures employed;
60.1.9. the site provided for processing after completion of activities with genetically modified organisms;
60.1.10. the genetically modified organisms for destruction or disruption of the operation to be carried out after the termination of the distribution in the environment;
60.1.11. the genetically modified organisms for the results of the previous distribution and information about them, especially the information about their distribution in different quantities and different ecosystems;
60.2. information on the environment (on the distribution site and surroundings): 60.2.1. the geographical location of the site, and coordinates (in the application of genetically modified organisms in the distribution market place is genetically modified organisms intended for use in the area);
60.2.2. physical and biological proximity to humans, flora and fauna;
60.2.3. the distance to the protected habitat of European interest, specially protected natural areas or nearby drinking water sampling sites;
60.2.4. the economic activity of the population, based on a specific area of the natural resources;
60.2.5. climatic characteristics of the district, who may be affected;
60.2.6. geographical, geological and soil characteristics;
60.2.7. flora and fauna, including crops, livestock and migratory species;
60.2.8. objectives and additional ecosystem that may be affected;
60.2.9. host's natural place of residence and the comparison of distribution;
60.2.10. any genetically modified organism distribution site known or planned developments or changes in land use, which could influence the distribution of space environment. 61. Genetically modified organisms and the environment:

61.1. a description of the circumstances that affect genetically modified organisms could survive, proliferate and spread unchecked: 61.1.1. biological features which affect the genetically modified organisms for survival, multiplication and dissemination;
61.1.2. known or predicted environmental conditions which may affect survival of genetically modified organisms, reproduction and uncontrolled spread (such as wind, water, soil, temperature, pH);
61.1.3. sensitivity to specific exposure factors;
61.2. effects on the environment: 61.2.1. for genetically modified organisms in the distribution;
61.2.2. research on genetically modified organism behavior, characteristics, and ecological impact, made them unusual environment, such as climate Chambers, growing rooms, greenhouses;
61.2.3. genetic transfer capability: 61.2.3.1. genetic material later (after distribution) transferred from the genetically modified organism to other organisms in certain ecosystems;
61.2.3.2. genetic material at a later date (after the distribution) transferred from indigenous organisms to the GMOs;
61.2.4. the probability that after genetically modified organisms in natural selection can lead to unexpected or undesired characteristic expression in genetically modified organisms;
61.2.5. measures taken to ensure and demonstrate genetic posts each. The description of genetic trait that can prevent or reduce the spread of genetic material. Methods used to show the genetic stability;
61.2.6. biological pathways, known or potential modes of interaction and the spread of contributory factors, for example, inhalation, ingestion, surface contact;
61.2.7. Description of ecosystems to which the GMOs could be disseminated;
38.1. the genetically modified organisms for potential impacts on the environment: 61.3.1. excessive population formation;
61.3.2. benefits of genetically modified organisms, competition with non-recipients or parental organisms;
61.3.3. target organism count and description;
61.3.4. the genetically modified organisms and the target organism intended interaction mechanism and result;
61.3.5. records of non-target organisms and which may be affected accidentally, and mechanisms for the prevention of these impacts;
61.3.6. possible changes in biological interactions or in a range of organisms present in the sējorg after the release of genetically modified organisms;
61.3.7. known or predicted effects on other organisms in the environment, impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens,
61.3.8. known or predicted involvement of genetically modified organisms in the fucking on biogeochemical processes;
61.3.9. other potential significant effects of genetically modified organisms into the environment. 62. Information on monitoring, control, waste treatment plan and contingency plan: 62.1. monitoring techniques: 62.1.1. methods for the genetically modified organism labelling and monitoring impacts;
62.1.2. surveillance methods, sensitivity, specificity and reliability to identify genetically modified organisms and distinguish it from the donor, recipient or parental organisms;
62.1.3. techniques to detect the modified transmission of genetic material to other organisms;
62.1.4. the monitoring duration and frequency of control measures;
62.2. contingency plan: 62.2.1. techniques and methods to prevent or reduce the spread of genetically modified organisms outside the distribution site or a specific area of Muggle artifacts;
62.2.2. techniques and methods, to delimit the proliferation of genetically modified organisms and prevent unauthorised access;
62.2.3. techniques and methods to prevent other unwanted organisms from genetically modified organisms;
38.7. processing of waste: waste type; 62.3.1.
62.3.2. expected amount of waste;
62.3.3. possible risk factors;
62.3.4. for waste treatment;
38.8. conduct in emergencies: 62.4.1. methods and procedures to be used in the control of genetically modified organisms, where the uncontrolled spread of it takes place;
62.4.2. methods used for conditioning and rehabilitation of the area;
62.4.3. methods for the genetically modified organism during or after the spread, which destroyed or sanitary handling of genetically modified organisms in exposed plants, animals and soil;
62.4.4. methods for the isolation of the area, in which genetically modified organisms;
62.4.5. protection of human health and the environment action plan, if genetically modified organisms occurs during unwanted consequences. 7.2. information contained in this application for higher plants release into the environment or market 63. information about the recipient or (where appropriate) parental plants: 39.2. full name-family, genus, species, subspecies, variety or selection line and common name;
39.3. information on reproduction: reproduction; 63.2.1.
63.2.2. Special reproduction-(if any);
63.2.3. generation length;
63.2.4. sexual compatibility with other cultivated or wild plant species;
63.3. survivability: 63.3.1. ability to make survival or over-wintering structures;
63.3.2. specific-survival (if any);
63.4. uncontrolled distribution capabilities: 63.4.1. uncontrolled distribution and quantity, for example, assess you, showing the viable pollen or seeds, they overcome the distance;
63.4.2. especially the uncontrolled spread of factors affecting (if any);
63.5. the geographical distribution of plants;
63.6. when specific species of plants are not grown in the Member State in which the proliferation of genetically modified organisms, the plant's natural site description (including information about natural enemies, parasites, competitors and symbionts);
the possible significance of 63.7. plant interactions with other organisms, the ecosystems in which it usually grows, including information on toxic effects on humans, animals and other organisms. 64. information describing the genetic modification: 64.1. Description of the methods of genetic modification;
64.2. used in the vector type and origin;
64.3. donor organism size, origin, taxonomic affiliation (nosa Kuma), modifications in the genome and its function. 65. information that genetically modified plants: 65.1. inserted or modified traits;
65.2. information about inserted or removed in the sequence: inclusion or deletion of 65.2.1. 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 of some other vector molecules part stores carrying genetically modified plant;
65.2.2. If the deletion has been made, cut the size of the fragment and the function;
65.2.3. the inclusion of space 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;
65.2.4. the number of copies to be inserted;
65.3. information about the inserted genetic information expression: 65.3.1. information about the type of expression of the insert and characterisation methods;
65.3.2. parts of the plant where the insert gets (e.g. roots, stem, pollen);
65.4. the plant from the recipient plant in: 65.4.1. reproduction form or intensity;
65.4.2. does not control the distribution of abilities;
65.4.3. survival skills;
65.5. genetic stability of the insert and phenotypic stability of the plant;
65.6. genetic transfer from plants to other organisms;
65.7. information on any toxic, allergenic or other harmful effects on human and animal health or the environment, if it occurs in the genetic modification process;
65.8. information about plant safety to animal health, particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the plant is intended for use in animal feed;
65.9. If possible, plant and target organisms, the interaction mechanism specification;
65.10. potential interactions with the abiotic environment, 65.11. potential interactions with various biotic environmental factors;
65.12. plant detection and identification methods;
65.13. information on the release of the similar experience (if any). 66. information about the location of the release (only for genetically modified organisms in the environment): 66.1. distribution site location and size;
66.2. Description of the release site ecosystem, including climate, flora and fauna;
66.3. the related wild or cultivated plant species, in the presence of plant species that are able to cross with certain genetically modified organism;
66.4. distance to the protected habitat of European interest and specially protected natural areas. 67. information relating to the release (only for genetically modified organisms in the environment): 67.1. redistribution;
67.2. expected distribution start date (month, quarter);
67.3. genetically modified plant distribution methods;

41.9. site preparation and distribution control method before the proliferation of genetically modified organisms, during and after them, including the growing and harvesting methods;
approximate number of 67.5. plants (or plants per square metre). 68. the information on monitoring, control measures at distribution and waste treatment plans: 68.1. precautions: determination of the distance to 68.1.1. Habitat, which is present in the related plant species;
68.1.2. all measures to reduce or prevent plant pollen or seed distribution;
68.2. the place of release of the pēcap work description of methods;
68.3. plant material (including waste) processing methods to be used (after their distribution);
68.4. monitoring program and description;
68.5. emergency measures;
68.6. distribution of space protection measures and methods. 8. additional information to be included in the labelling of genetically modified organisms and genetically modified organisms in the iesniegumāpar release 69. Application on the market genetically modified organisms on the market in addition to the provisions of section 7.1 and 7.2 information: 69.1. the trade name of the product, or that which is obtained from a genetically modified organism, and the products contained in the genetically modified organism names, any specific identification, name or code that the person used to identify genetically modified organisms;
EB 69.2. its Union logged a person's name and address (legal person – name and legal address), which is responsible for distribution in the market (whether that person is a manufacturer, importer or distributor);
69.3. the applicant's name, the control name and address (legal person – name and legal address);
69.4. genetically modified organisms use description that highlights the differences in genetically modified organisms and genetically modified organisms not in use;
69.5. the geographical area or media type, in which genetically modified organisms intended for use, if possible, including details of the intended use;
72.2. intended use, such as industry, agriculture, specific trade or unrestricted distribution in the retail trade;
69.7. information on the genetic modification for use in particular of genetically modified organisms. This information shall indicate, where appropriate, the competent institution, in which genetically modified organism or its genetic material and details of nucleotide sequences or other types of information necessary to identify genetically modified organisms and its descendants, such as genetically modified organism detection methodology, including the data for release into the environment, reflecting the specificity of the methodology. Indicates which is the limited availability of information and not insert registry;
69.8. for genetically modified organism labelling on a label or in an accompanying document. The label says, access to the information in the registry is part of the general public. The labelling shall include, at least in summary form: 69.8.1. the trade name of the product, or that which is obtained from a genetically modified organism;
69.8.2. "this product contains genetically modified organisms";
69.8.3. name of genetically modified organisms;
69.8.4. This provision EB 69.2. information referred to in the subparagraph. 70. in addition to these regulations, paragraph 69 information pursuant to this paragraph, the provisions of 15.6.: 70.1. protection measures, if genetically modified organisms spread unchecked or inaccurate;
70.2. specific instructions or recommendations for storage of genetically modified organisms and other activities with them;
70.3. specific instructions for monitoring and reporting in accordance with the monitoring programme;
43.7. the proposed restrictions on the use of genetically modified organisms authorization, such as the use of genetically modified organisms within the scope and purposes;
70.5. type of packaging envisaged. The packaging must be such as to prevent genetically modified organisms inadvertently spread it during storage and distribution;
70.6. estimated production or import volumes in the European Union;
70.7. proposed additional labelling requirements. They include the formulation of this provision, 69.5, 69.4 70.1 70.2 70.3, 70.4, and the information referred to in the paragraph below. 9. the genetically modified organisms in the distribution market monitoring programme development and monitoring 71. a Person develop a monitoring program for dissemination of genetically modified organisms on the market on a case-by-case basis, taking into account the environmental risk assessment, in particular genetically modified organism-specific change characteristics, intended use and the receiving environment. 72. The effective and general monitoring program before the start of the monitoring carried out genetically modified organism environmental risk assessment in accordance with the legislation on genetically modified organisms for the risk assessment methodology. 73. the objectives of the Monitoring Programme are: 73.1. confirm that is correct environmental risk assessment relating to the genetically modified organism or its usage potential harmful effects;
73.2. identify environmental risk assessment in genetically modified organism or its use harmful effects on human and animal health or the environment. 74. Monitoring Programme for the development of the main principles are as follows: 74.1. monitoring shall be carried out after the authorization of genetically modified organisms in the distribution market;
74.2. monitoring data interpreted in the light of the different environmental conditions and activities. If changes in the environment are observed, it is necessary to further environmental risk assessment to determine whether they are 74.2.1:. genetically modified organisms use consequences;
74.2.2. they have other environmental factors, which are not proposed the distribution of genetically modified organisms on the market;
46.2. developing a monitoring program, the use of information and data produced by genetically modified organisms in the environment. 75. The Monitoring Programme has the following main parts: 75.1. the strategy;
75.2. the methodology;
75.3. analysis, reporting, review. 76. developing the monitoring program: 76.1. each case assessed individually, taking into account the environmental risk assessment;
76.2. take into account the characteristics of the genetically modified organism, intended use and scope and specific environmental conditions, which distribute genetically modified organisms;
76.3. include general monitoring and, if necessary, case-specific monitoring focusing on adverse effects of the discovery, which was identified in the environmental risk assessment, taking into account that: 76.3.1. each case long enough implemented specific monitoring event to discover instant and direct exposure, as well as, where appropriate, delayed and indirect effects, which are identified in accordance with the environmental risk assessment;
76.3.2. in the implementation of the general monitoring, if necessary, using existing monitoring programmes, such as biodiversity, soil quality, plant pest and disease monitoring programs;
76.4. plans to systematic surveillance for genetically modified organisms in the ecosystem and the interpretation of observations in relation to the safety of human and animal health or the environment;
76.5. determine the persons responsible for monitoring programme implementation of the tasks set out in, the development of programmes for the monitoring and proper implementation, as well as ensure that the holder of the authorisation shall inform of the observed adverse effects on human and animal health or the environment. points time and intervals for reporting monitoring results;

47.6. provides mechanisms for all adverse effects observed for identification and approval and the ability of a person or Department to take measures to protect human and animal health or the environment. 77. In certain cases, the monitoring programme will include case-specific monitoring, to identify genetically modified organisms in the distribution market of the potential impacts identified in accordance with the environmental risk assessment. 78. the Monitoring Programme will also include general monitoring, which helps determine the unforeseen or accidental harmful genetically modified organism. Specific impacts made on the basis of the environmental risk assessment and scientific information available. Potential impacts are identified, the appropriate time to plan the overall monitoring. 79. in the light of the instructions in this chapter, shall assess the case-specific monitoring and general monitoring of the cost-effectiveness. Monitoring programme drawn up on the basis of the latest scientific knowledge and practice. 80. in interpreting monitoring results obtained, take account of existing environmental conditions and activities carried out for the determination of baselines. Similarly, you can use the general monitoring and environmental monitoring programs. If not for the environment are observed, should change, consider the possibility of further risk assessment to determine whether a change is found, the consequences of genetically modified organisms on the market or other factors. In the context of their consideration of human and animal health or the environment. 9.1.81. Monitoring Strategy Monitoring strategy is important to determine the potential effects that may arise at the time when genetically modified organisms are distributed in the market, the degree to which it must be monitored, as well as the method and the monitoring period. 82. The Monitoring Strategy considering how great is the probability that the genetically modified organisms will result in direct, indirect, immediate or delayed adverse effects, taking into account its intended use and the receiving environment. 83. the Monitoring strategy, as approved by the environmental risk assessment to identify the potential harmful effects of genetically modified organisms in accordance with the use and the receiving environment. This takes into account the environmental risk assessment conclusions and assumptions, which are based on a scientific evaluation by the scientific experts and the opinion of the Commission. In addition, the monitoring strategy also includes the issues arising from the environmental risk assessment process and what is not clear, for example, the possible effects of genetically modified organisms that can occur, the distribution of genetically modified organisms in bulk. 84. in the formulation of the Monitoring Programme may use all general information pertaining to the genetically modified organism, including the data and the information obtained when genetically modified organisms are distributed in the environment, as well as information from scientific publications and relevant comparable evidence obtained from other genetically modified organisms. Particularly useful are the data obtained from the available risk research and dissemination environment monitoring. 85. the Monitoring method: 85.1. describe method of monitoring strategy, addressing the main possible risks and cyclical process of monitoring, to continuously improve the quality of the monitoring programme;
85.2. provides the means by which genetically modified organism found potential harmful effects in early stage of expression. Any genetically modified organisms with associated harmful effects of early detection allows you to quickly re-evaluate and implement measures to reduce the consequences of any environment. 86. The genetically modified organisms for monitoring programming takes place gradually, taking into account existing data, monitoring methodology, as well as the proliferation of genetically modified organisms. The first stage valued results at a time when genetically modified organisms are distributed in the environment and market. Developing genetically modified organisms in the distribution market monitoring program uses information gained in the course of genetically modified organisms in the environment. 87. the monitoring of genetically modified organisms needs you can also customize the existing monitoring programs to ensure comparability and to reduce the costs of resources to develop the method. This applies to existing environment Moni toring programs in agriculture and biodiversity conservation in the long term ecological monitoring programs, soil observation and veterinary studies. For such an adaptation of an existing application monitoring programme to a person agreed upon by the competent authorities in question. 88.84 these provisions applies to specific monitoring and general monitoring according to the objectives laid down in this chapter, but also allows other types of application monitoring. 89. the Case-specific monitoring method: 89.1. analyzes their possible harmful effects on human and animal health or the environment identified in the risk assessment, taking into consideration the genetically modified organisms in different locations, soil types, climatic conditions;
89.2. the exact period for which results are obtained. 90. the Case-specific monitoring is the first phase of the monitoring strategy. Also determine the assumptions about genetically Modifi Ed organisms or its potential harmful effects of use are set out in the environmental risk assessment, and in certain cases it is confirmed by the case-specific monitoring. If the conclusions of the environmental risk assessment is identified the absence of risk or negligible risk, case-specific monitoring is not necessary. 91. environmental risk assessment identified possible adverse effects include monitoring programme, taking into account that the monitoring results, you can approve or reject the assumptions relating to these effects. 92. If the cultivation of genetically modified organisms, evaluated for monitoring pollen transfer and genetically modified organism resistance. The degree to which there is a probability that this phenomenon also depends on the use of the genetically modified organism and the receiving environment, including from non-genetically modified crops and related species of wild relatives near and volume. 93. The potential environmental risks posed by genetically modified organisms, which are only allowed to be imported and processed, and can be evaluated fully restrict, if not genetically modified organisms released into the environment, and if they are not typically spread. 94. Potential impact on human and animal health or the environment arising from the release of genetically modified organisms into the environment or the market, depends on genetically modified organism's characteristics and its specific genetic information in modifik, for example, the possible impacts caused by the transfer of pollen from genetically modified crops to non-genetically modified crops or cause trivial in wild plants, mainly depends on whether the genetically modified crops crosses or self-pollinating. Also consider the presence of related wild plants. 95. in the future, for example, the possible development of resistance of insects to the Bacillus thuringuns (Bt) toxin is only related to genetically modified organisms, modified, to eliminate 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. 96. It is also important to monitor possible antibiotic resistance gene transfer and the potential consequences could lead to genetically modified organisms, which would transform the content of antibiotic resistance genes. 97. on target detection based on potential exposure, identify the parameters by which these objectives can be achieved. The parameters and the methods of measurement and evaluation must be valid and appropriate for this purpose. 98. General monitoring is the periodic observation, and it is used to identify genetically modified organisms unpredictable adverse effects or usage that is not listed in the environmental risk assessment, but is harmful to human and animal health or the environment. This includes phenotypic characteristics and also allows more detailed analysis. 99. General monitoring: 99.1. identify and record any indirect, delayed and cumulative adverse effects not mentioned in the risk assessment;

use the longer period of 99.2. and the greatest possible area. 100. General monitoring (including the location, area and all the parameters to be measured) largely depends on the unexpected harmful effects study, for example, to monitor the unintended adverse effects on the ecosystem of cultivated as changes in bio-diversity and multiple distribution and interactions of the cumulative environmental effects, it may be necessary for other general monitoring method than to monitor the different impact of gene transfer. 101. General monitoring, you can use traditional periodic Monito ring, such as agricultural crops, plant protection, monitoring of the medicinal product, as well as ecological monitoring, environmental monitoring and conservation of biodiversity program. The monitoring programme may also contain details of how to obtain the specific information collected by third parties in the periodic monitoring of the traditional, or how that information has been made available to the person. 102. If the general monitoring using traditional periodic Monito ring, describes both the practices and the changes that are necessary to carry out general monitoring. 103. the baseline condition of the receiving environment is a prerequisite for the identification of change observed in the monitoring and evaluation. The base line is a point of reference with which to compare any effects caused by genetically modified organisms. Therefore, the baseline is determined before attempting to detect and monitor any impact. Parallel to the genetically modified organism and the comparative monitoring of areas that contain no genetically modified organisms, may be an alternative, and can have a role, if the environment is particularly dynamic. 104. adequate environmental observation systems based information on the receiving environment conditions may be necessary before the monitoring programme and the implementation of environmental policy measures. Environmental monitoring plan programs to take into account the proven, reliable or possible ecosystem relationships, and it can be useful to determine: the State of the environment and 104.1. change it;
104.2. reasons for change;
104.3. the expected development of the environment. 105. The receiving State indicators can include animals, plants and micro-organisms from different groups of organisms and ecosystems. Certain indicators can be assessed on the basis of the genetically modified organism in accordance with the characteristics and parameters to be monitored. May be other organisms ability to intersect with genetically modified organisms. The specific indicator species has several possible measurement parameters or fitness variables including growth rate, count, biomass, reproduction, population gain or loss rate and genetic diversity of similarity. 106. it is appropriate to assess the baseline for change the saimn setting in practice, arising from the use of genetically modified organisms. These may include changes in the use of pesticides in cereals crops in cultivation, the species which have been genetically modified for herbicide tolerance and insect resistance. Considering a monitoring programme that crops are genetically modified, herbicide-tolerance can assess herbicide usage of non-genetically modified crops, adopting the appropriate baseline. 107. Monitoring shall be carried out in the period which is sufficiently long to open, if necessary, not only to the probable immediate impact but also the late effects that are identified in the environmental 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 focus on late and indirect impacts, assessing whether the monitoring programme shall be limited to the period after the agreed period of time. It can be, for example, if genetically modified organisms are particularly persistent in the environment. 108. the proposed monitoring programme indicate the period, including the frequency of possible control and review of the monitoring programme. Take into account the impact of any such manifestations, which are set out in the environmental risk assessment, for example, assess any adverse effect that causes the release of genetically modified organisms, persistence or reproduction and 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 species of cereal crops can be several years. The same order of modification and the likelihood of sustainability examined in the case the intersection options with related plants. 109. the planning of control primarily depends on the kind of impact to be monitored, such as impact, caused by pollen transfer, gets just after flowering, it is therefore appropriate to visit the territory before flowering, to assess what is the proportion of related plants. Likewise, the emergence of volunteer plants in subsequent periods of growth monitoring in connection with the spreading of seed time and subsequent seed bank persistence and germination. 110. the visits are also required before the start of the monitoring, to determine the specific baseline. 111. The Monitoring Programme shall be determined during the period reviewed and amended in accordance with the results obtained in implementing the monitoring programme. 112. the service shall provide the monitoring program in accordance with the provisions of subparagraph. 25.4 The adequacy of the monitoring programme presented is one of the criteria to evaluate any submissions of genetically modified organisms on the market. The monitoring program is assessed only on the basis of whether it is sufficient for the requirements of these regulations. 113. the genetically modified organisms for arrange the distribution market person na monitoring programme performance and reporting in accordance with the conditions of the permit. 114. the Monitoring Programme shall establish the responsibilities and the case-specific monitoring and general monitoring. The above monitoring is the monitoring of the components of the programme. The person is responsible for monitoring the implementation of the third-party is permitted – consultants and growers ' involvement in monitoring – to perform a variety of monitoring in specific tasks. General monitoring may involve the European Commission and the competent authorities of the other Member States. Employing third person or latch with them on contract for carrying out monitoring, monitoring programme details the involvement of those persons in the scheme. 115. the service can perform additional monitoring. Additional monitoring may be case-specific monitoring or general monitoring. This is the objective of Monito ring given the risk manager the opportunity to immediately take appropriate measures, in accordance with the environmental risk assessment carried out in the event of unwanted or unidentified. However, additional monitoring cannot replace the monitoring, which is the responsible person. 116. it is possible to expand existing monitoring programs or the general monitoring program, the likelihood of adverse effects caused by genetically modified organisms. These programs include Germany's agricultural, food, biological diversity, long term ecological monitoring programs, as well as environmental monitoring and health surveillance surveillance monitoring applications, such as monitoring of seed production in the program comply with the Organisation for economic cooperation and development (Organization for Economic Co-operation and development) (hereinafter referred to as OECD) certification rules and so the field and the surrounding area for periodic surveillance and control, you can adjust the parameters specified for monitoring in the field. 117. sale of genetically modified seeds can introduce additional services that merchant or hired consultants at least some of the general types of monitoring. Instructions relating to the monitoring and reporting, can be distributed to growers who buy genetically modified seeds, and the provisions of the Treaty can formulate sales or terms of use. 118. Instructions designed to growers and agricultural consultants could study the major unexpected changes or impact, such as the volunteer introduction of plant propagation and growing areas adjacent. In these circumstances it is expected that the monitoring of adverse effects may include periodic practice and that it is used to determine the agricultural plant protection products, plant pathogens, pests and weed suppression. 9.2.119. Monitoring methodology based on environmental risk assessment on a case-by-case basis, identifying the effects parameters and elements, taking into account the changes made in genetically modified organism. Also assess the appropriateness of monitoring intended effects on target organisms, such as the corn borer population monitoring in relation to the cultivation of Bt maize varieties. 120. As part of the monitoring programme may also consider elements that are not specific, such as:

120.1. 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;
Introduction 120.2. dissipation and persistence in the environment or ecosystems that are not the target environment or ecosystems;
120.3. crossover frequency, type, and intensity, with sexually compatible wild relatives in natural populations of organisms;
120.4. unforeseen changes in the basic organism, such as a change in the number of replica offspring, growth, and survival of the seed;
120.5. the changes in biological diversity, such as the number or composition of species. 121. the Monitoring Programme may include information on where and how big will the monitoring area. It can be specified individually by Member State, geographical regions, territories, land or, if necessary, other areas. 122. Identify areas to be monitored and samples (including areas and samples for the report or control) in regard to possible effects caused by genetically modified organisms. All the areas and for the sample report, or control, is sufficiently representative for the environment and conditions of use, to get meaningful conclusions, and sampling methodology is scientifically and statistically justified. Of the following sound data can be obtained important information on indicators of change, and hence increase the impact detection ability. 123. the areas to be monitored (for example, in the case of genetically modified cereals 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 the important monitoring areas are designated agricultural areas where crops are grown commercially, and the surrounding Habitat. 124. the Monitoring extended to adjacent or neighbouring cultivated and non-cultivated areas, as well as to the areas after harvest monitor volunteer plants, and specially protected natural 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 especially suitable for monitoring because they are widespread, often located close to more intensive agricultural areas cultivated, is typical of roadsides, ditches and edges of fields, which usually occurs in early accidental loss and dispersion of seeds. 125. Consider also the possibility of monitoring, if the transfer of genetic material to a related organic and non-genetically modified crops. Consequently, assess the extent to which these plants are grown in culture in adjacent or neighbouring areas. 126. the Monitoring program indicates the expected frequency of control and surveillance. It may include graphics, stating the intended area and number of visits. In view of this provision, 107, 108, 109, 110, 111, 124.123 and 125, assess, during which potential adverse effects the most gets and which areas need to be monitored. 127. This provision, paragraph 119 and the parameters element Monito ring, including sampling and analysis is required to set out clearly and identified. If the standard is applicable to the methodology established by the European Committee for Standardisation (European Committee for Standartization) standards and OECD methods for genetically modified organisms Monito ring environment, they follow and indicates the source of the methodology. Monitoring the use of the method in Toyama is scientifically sound and valid distribution environment conditions in which they are used, so evaluate the characteristics of the methods, such as selectivity, specificity, reproducibility, any limitations, sensitivity, as well as the availability of a particular control sample. 128. The Monitoring Programme shall specify the manner in which articulates the methodology in accordance with the monitoring method or strategy. 129. In designing the appropriate sampling and analysis methodology can also be used for statistical analysis to determine the optimum sample size and shorter periods of monitoring in specific detection of impacts with the necessary statistical accuracy. 130. The Monitoring Programme in relation to the specific case of the ring and monito general monitoring indicates how, who, and how often to collect and process the data. This is particularly relevant when the data collection in the employ or hire to third parties. The person collecting and recording data, based on predetermined action and standard documents to ensure consistency (for example, using a standardised registration form or provides direct data logging standardized spreadsheets). The person also describe how the data are processed, and receives information from third parties, such as consultants or producers. 9.3. Analysis, reporting and review of 131. Monitoring Programme indicate the dates and intervals to reporting the results of monitoring, as well as how often the data review and amend the general analysis. 132. the Monitoring data of the results of assessment, if necessary, include statistical analysis with the appropriate values of the standard deviation to be able to make informed future decisions, including decisions on whether the risk assessment conclusions are correct. The accuracy of the estimates is primarily determined by how correct is the baseline and controls relating to the receiving environment. Statistical analysis gives information on whether a particular methodology, including sampling and analysis is appropriate. 133. monitoring and evaluating the results of the studies can determine whether you need to monitor other parameters specified in the monitoring program. Also check previous findings (especially if there is evidence of possible undesirable effects on habitats and organisms susceptible groups). 134. 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 a change is caused by such environmental factors, which are not genetically modified organisms on the market. Repeating the base line, which is used for comparisons in this aspect. 135. the design of the Monitoring program is that casual specific monitoring, general monitoring and additional research results can not be used over the course of a decision on the renewal of the distribution market. 136. The reports on the results of monitoring shall be submitted by the person in the service of the European Commission and the competent authorities of the other Member States in accordance with the conditions laid down in the authorisation. 137. the Monitoring Programme will also indicate how relevant information collected within that time or during periodic monitoring, provide person and other competent institutions of the Member States. 138. the Person provides the transparency and monitoring of the results of the program dictates how information gathered or submitted to be published. It can be done, for example: 138.1. with the information sheet provided for farmers and other persons in the region of resētaj;
138.2. with workshops where information presentation and exchange with stakeholders;
138.3. archived merchant internal documents;
inserting information merchant 138.4. websites;

138.5. industry and the public with information in scientific publications. 139. the review of the information and conditions specified in the application. 140. the Monitoring program is not considered static. It is essential to the monitoring program and the associated methodology for review by the appropriate intervals and, if necessary, to restore and customize. 141. the Department, on the basis of the monitoring reports submitted by the parties, are allowed to adjust the monitoring programme after the first monitoring period. On the revised monitoring program is the responsibility of the person. 142. the service review of the monitoring programme, the data collection, measurement, as well as sampling and analysis of efficiency and quality. Review of the monitoring programme, also assess the effectiveness of the monitoring criteria for ratings, and shall examine all issues arising from the risk assessment. 143. When forecasting uses special models, you can make an estimate, based on data collected and subsequent calculation. If necessary, must take into account the methods of sampling and analysis of innovation and development. 144. following the review of the methods of correction is required, the monitoring of targets and monitoring programmes according to the adjustment or improvement. 10. the design of the report on genetically modified organisms to the environment monitoring results 145. In accordance with the conditions laid down in the permit the distribution of genetically modified organisms into the environment, the person subject to authorisation in certain intervals, based on the environmental risk assessment shall be submitted to the service (if possible through electronic mail) a report on the distribution of genetically modified organisms in the environment of the monitoring results (hereinafter referred to as the message) according to the rules laid down in annex 3. 146. A message applies only to a single distribution permit identifies the appropriate submission number. 147. a Person shall submit a final report and, if necessary, the end of the post-release monitoring report as well as post-release monitoring report. The report shall be drawn up in accordance with the report format. 148. The final report shall be delivered after the last GM crop harvest. If the application is not intended for post-release monitoring, additional messages are not necessary. 149. Post-release monitoring report shall be submitted to the end of the post-release monitoring. If necessary, service the authorisation shall specify the duration of the monitoring pēcizpl rolling as well as post-release monitoring report submission schedule. 150. the service can request additional information indicating the distribution of genetically modified organisms in the environment of the results, such as a log or interim reports that must be submitted when genetically modified organisms are distributed in the environment. 151. a Person reflects information collected through charts, pictures, and tables. If necessary, also provide statistical data. 152. If genetically modified organisms into the environment occurred in several places, several times and was a perennial, the person shall provide a general overview of the measures taken and the effects observed throughout during reconciliation. Informative reference to European Union directive contained in the provisions of the law, which stems from 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. The Prime Minister, the children, family and integration Affairs v. dombrovsky, Agriculture Minister Minister of environment r. vējonis annex 1 Cabinet 26 May 2009. Regulations No 457 farming Minister – the Minister of the environment r. vējonis annex 2 Cabinet 26 May 2009. Regulations No 457 farming Minister – the Minister of the environment r. vējonis annex 3 Cabinet 26 May 2009. Regulations No 457 farming Minister – the Minister of the environment r. vējonis

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