Cabinet of Ministers Regulation No 1078 of 2008 in Riga on 22 December (pr. No 94 53) genetically modified organisms for the risk assessment methodology Issued in accordance with the movement of genetically modified organisms Act 5 of the first paragraph of article 3 i. General questions 1. determines the genetically modified organisms for the risk assessment methodology. 2. the genetically modified organisms for the risk assessment, the goal is to identify and evaluate the potential for genetically modified organisms harmful direct and indirect, immediate or delayed effects on human and animal health or the environment that may result from certain genetically modified organisms into the environment or the market. Based on the environmental risk assessment, appropriate risk management measures, and monitoring methods to be used. 3. If genetically modified organisms on the market (hereinafter referred to as the distribution market) also includes the distribution of genetically modified organisms in the environment (hereinafter referred to as the propagation environment) (for example, genetically modified organisms in products for use in human food, animal feed and processing), the application shall include a risk assessment. II. General environmental risk assessment principles 4. In accordance with the precautionary principle, shall assess the environmental risks, taking into account the General environmental principles of risk assessment. 5. General principles for the environmental risk assessment are as follows: 5.1 identify genetically modified organism characteristics that can lead to potential adverse effects, taking into account the environment or the market for distribution and use. Genetically modified organism characteristics that can lead to potential adverse effects are determined by comparing the characteristics of the genetically modified organism with its own characteristics of the organism, which is not genetically modified, and is derived from the genetically modified organism;
5.2. to describe the State of the environment or environmental base line before distribution environment, while still can not identify any (harmful) characteristics of the genetically modified organism. The base line is a point of reference with which to compare future changes, which may cause a release into the environment or the market. The base line is dependent on the receiving environment, including biotic and abiotic factors (e.g., stored in natural ecological environment, farmland or contaminated land), or various combinations of environmental conditions. If the distribution market, describes the environmental base line, which is genetically modified organisms will be distributed (to grow);
5.3. to determine and specify the genetically modified organism, the long-term cumulative effects. Information on the long-term cumulative effect allows the assessment of genetically modified organism in adverse effects on human and animal health or the environment, including flora, fauna, soil fertility, organic matter degradation processes, food chain, biological diversity and resistance to antibiotics in organisms. Information and data on the long-term cumulative effect gets prolonged period, assessment of: 5.3.1. genetically modified organism in the receiving environment interaction (which is genetically modified organisms will be distributed);
5.3.2. the genetically modified organism characteristics that may cause long term adverse effects for human and animal health or the environment;
5.3.3. the genetically modified organisms in the environment or in the case of distribution market;
5.3.4. the genetically modified organisms in the environment, or other common genetically modified organism in a similar way to the modification of the monitoring results and adverse effects on human and animal health or the environment; 5.4 specify used in the environmental risk assessment methods and scientific publications on environmental risks. Environmental risks are analysed, using the European food safety authority guidelines (guidelines available from the European food safety authority home page on the internet at http://www.efsa.europa.eu) and recognized scientific publications;
5.5. to specify a description of the methods used in scientific publications, calculations and measurements measurement inaccuracies;
5.6. specify the distribution environment or market risk management measures to determine the data about the environmental base line, if such data are not available. Data on the environmental base line are such as to allow to estimate the risk of the significance of the genetically modified organism. If the environmental risk assessment does not give definitive answers to all the questions under consideration because of the lack of data or data are not available or are incomplete (particularly in relation to the possible long-term effects), then in accordance with the precautionary principle, risk management measures to avoid adverse effects on human and animal health or the environment; 5.7. action taken to follow it step-by-step. First launch of operation in enclosed spaces, such as greenhouses, thus determining the genetically modified organism, the possible harmful effects on human and animal health or the environment; 5.8 to keep separate the environmental risk assessment for each organism genetically modified and its use and dissemination of environment or the market. Environmental risk assessment can be used similar to the genetically modified organism data that has similar characteristics and similar interactions with the environment, 5.9. genetically modified organisms indicate the likelihood of adverse effects on other genetically modified organisms that are distributed or environment or the market concerned;
5.10. to carry out the environmental risk assessment and to inform the food and veterinary service, if: a new 5.10.1. obtained information and there is reason to believe that the risk of people changed and animal health or the environment;
5.10.2. the need to make changes to risk management measures;
5.10.3. in analysing the results of the monitoring are identified risk for genetically modified organism. III. Environmental risk assessment 6. evaluate environmental risk for each individual organism has been genetically modified using environmental risk assessment guidelines (guidelines available from the European food safety authority home page on the internet at http://www.efsa.europa.eu), scientific publications and the latest scientific knowledge. 7. environmental risk assessment shall include the following: 7.1. information relating to the genetically modified organisms in accordance with the provisions of paragraph 8;
7.2. the opinion on genetically modified organism, the effects on human and animal health or the environment in accordance with paragraph 9 of these regulations;
7.3. Summary of the environmental risk assessment in accordance with paragraph 10 of these regulations. 8. information about genetically modified organisms include: 8.1. detailed analysis of: 8.1.1. used for the genetic modification recipients, donors, vectors and the parental organisms;
8.1.2. the process of genetic modification, whether inclusion or deletion has been made operational, as well as information on the vector and the donor;
8.1.3. the genetically modified organisms in the body;
8.1.4. the prescribed form of distribution, its scale and applications;
8.1.5. the potential receiving environment;
8.1.6. the rules referred to in point 8.1 characteristics of interaction;
8.2. analysis of the genetically modified organism characteristics that could lead to potential adverse effects on human and animal health or the environment and possible consequences. Genetically modified organism in the harmful effects of this provision are listed in chapter IV. Genetically modified organism characteristics that could lead to potential adverse effects shall be determined as follows: 8.2.1. compared genetically modified organisms and the characteristics of the organism, which is not genetically modified, and is obtained from a genetically modified organism, taking into account the distribution and usage. Crops are produced vegetatively, compared with the parental species, which is used in the creation of genetically modified crops. Crops, which breeds sexual way, comparative analysis is carried out with appropriate izogēnaj lines;
8.2.2. Description of the genetically modified organism or its genetic origin structure, which can lead to potential harmful effects;
8.2.3. the detailed analysis of the genetic modification, altered genes and their products (such as proteins), to assess the potential harmful effects;
8.2.4. evaluate and specify the genetically modified organism harmful effects according to this provision the requirements contained in chapter IV. The manner of the release shows how genetically modified organism getting into and distribution in the environment and how you may cause possible adverse effects (e.g., inhalation of toxic microorganisms or toxic proteins);
8.2.5. evaluates the genetically modified organism into the environment, describing the distribution: 8.2.5.1. genetically modified organisms of biological fitness (indicating whether the genetically modified organism possesses qualities that give it a competitive environment in which it distributed, as well as indicate whether the genetically modified organism is resistant to natural random effects, such as abiotic factors);
8.2.5.2. genetically modified organisms in the distribution conditions (for example, genetically modified organism distribution scale) and specifying distributed quantity of genetically modified organism (number);
8.2.5.3. dissemination in the environment or market, as well as the probability of accidental spreading, taking into account the same non-genetically modified organisms, probability;

8.2.5.4. viable genetically modified organism material distribution (such as a seed, Spore, pollen distribution by wind, water, animals);
8.2.5.5. the specific environmental conditions of release into the environment (for example, location or region-specific conditions, favourable conditions conducive to genetically modified crops and wild plant related crossover options);
8.2.5.6. the genetically modified organisms in the life cycle and its viability in different habitats;
8.2.5.7. the genetically modified organism, the reproduction, survival and dormant forms (such as plants, pollen, seeds and vegetative structures, the viability of the micro-organism, Spore viability or the mikroorg ability to become viable organisms present);
8.2.5.8. the specific aspects of the environment. To assess each separately place or region, analyze data classified by Habitat areas, indicating the botanical data on genetically modified organism related wild species in the different agricultural production (conventional, genetically modified organisms or organic agriculture) areas or habitats of the European species natural range within the area;
8.2.6. evaluate the characteristics of the genetic material in the ability to integrate into other organisms, whether genetically modified organism is carried out gene transfer that could cause adverse effects to human and animal health or the environment. Gene transfer to other species is dependent on: 8.2.6.1. genetically modified organism in reproductive characteristics, genetic material, the characteristics of the genetically modified organism in the receiving environment and the type of the recipient;
8.2.6.2. spreading factors and specific environmental factors (for example, climate, wind);
8.2.6.3. reproduction of organisms. Assess higher plants and animals possible gene transfer on related, remotely related and non-related species, as well as assess the horizontal gene transfer of micro-organisms. Evaluation of micro-organisms that can quickly grow and multiply, they may contribute to the high level of gene transfer;
8.2.6.4. agricultural practices. Most genetically modified crops areas gene transfer will vary from small areas. Genetically modified organism can be invasive in the environment and out-compete the existing species of genetically modified organism viability is enhanced with the help of genetic modification. Adverse effects of the implementation of the proportional distribution of the genetically modified organism type;
8.2.6.5. the distribution of the organisms and the recipient environments that genetically modified organisms may intersect. Transgenic transfer for a fixed period could result in a new combination of genes spread in the environment in the long run can cause significant adverse effects;
8.2.6.6. pollination promoters (such as from insects or animals);
8.2.6.7. the presence of hosts not parasites;
8.2.7. evaluate and specify the genetically modified organism, phenotypic and genetic instability. If transgene expression is restricted to certain passages of the genetically modified organism, then assume that the tuning instability can cause the transgene expression throughout the body. If specific infertility transgenes barren is obtained from the genetically modified organism, then assume that there is a likelihood that the infertility transgenes do not result in stability of the genetically modified organism can restore fertility and therefore will be uncontrolled transgene spread. This evaluation will take into consideration that the transgene stability is not only in the newly created genetically modified organisms, but also being in which could be seen in changes in the long-term monitoring results. Genetically modified organism characterized by stability: genetically modified plants 8.2.7.1. line that contains more than one transgene. If further separation process in the trans gene distribution can create progeny plants with less transgenes, having obtained a new phenotype of the organism;
8.2.7.2. weakened mutants their instability. Certain mutations in the structure of the genetically modified organism can be restored to virulence;
8.2.7.3. transgenic, causing gene novājināšano;
8.2.7.4. the number of copies that is too large;
8.2.7.5. transferable elements. If the trans inactivates the genes with the inclusion of mobile genetic elements, inclusion in the new phenotype;
8.2.7.6. a significant level of transgene expression (for example, very little of toxic substances and the regulatory element of instability may increase the expression of transgenes);
8.2.7.7. interaction with the environment of the genetically modified organism during production, therefore, assess the environmental and agronomic factors on transgenic expression;
8.2.8. an assessment and specifies the genetically modified organism interactions with other organisms and their harmful effects according to this provision the requirements contained in chapter IV. Assess the possible interactions with other organisms, as well as with other genetically modified organisms, taking into account the complexity of the interactions between multitrofisk. Genetically modified organism harmful interaction takes place directly, if the observable: 8.2.8.1. effects on people (for example, persons who have direct contact with genetically modified organisms);
8.2.8.2. impact on animals;
8.2.8.3. competition between genetically modified and non-genetically modified organism on Earth, growing area, water, light;
8.2.8.4. populations of other organisms izkonkurēšan;
8.2.8.5. release of toxic substances;
8.2.8.6. different growth patterns;
8.2.9. evaluates the genetically modified organism environmental impact, taking into account good agricultural practice: 8.2.9.1. sowing or planting, growing, harvesting or transporting and its time;
8.2.9.2. crop rotation (for example, one species of plant growing every year or every fourth year);
8.2.9.3. disease or pest control mechanisms (for example, type and dose of insecticide plants or antibiotics and gave the animals);
8.2.9.4. resistance management (for example, type and dose of herbicide for herbicide-tolerant plants, or change in the biological eradication with Bacillus thuringiensis (Bt) proteins or viral effect);
8.2.9.5. agricultural and aquaculture system isolation measures (such as crop isolation distance or quality of isolation in fish farms);
8.2.9.6. the types of agricultural production (crops, genetically modified crops and conventional organic crops);
8.2.9.7. risk management measures (such as isolation distance control between natural habitats and genetically modified crops areas);
8.3. the genetically modified organisms and the use of possible adverse effects and effect assessment, as well as the specific significance of adverse effect according to chapter IV of these regulations;
8.4. analysis of genetically modified organisms in the possible harmful effects of probability of accession, taking into account its environmental baseline data, in which genetically modified organisms will be distributed. Describes each feature of the genetically modified organism, which can cause possible adverse effects on human and animal health or the environment, showing the harmful effects of probability and consequence of accession. To determine the harmful effects of probability, indicate the following information: 8.4.1. the size of the area in which it is intended to distribute genetically modified organisms;
8.4.2. the receiving environment, which provides for the distribution of genetically modified organisms;
8.4.3. the circumstances in which it is intended by genetic modified organisms spread environment;
8.4.4. climatic, geographic, and demographic conditions of the soil, flora and fauna as well as the type of receiving environment;
8.4.5. the viability of the genetically modified organism, without taking into account the proposed risk management measures. Evaluate and describe about genetically modified organism quantity (number), which can survive in the environment for the spread of genetically modified organisms;
8.4.6. the probability of gene transfer from genetically modified organism to other organisms. In this case, indicate the possible extent of gene transfer and the number of affected organisms;
8.4.7. organisms that specific receiving environment may affect genetically modified organism toxic characteristics;
8.4.8. the probability of adverse effects of the intervention to other organisms. The harmful effects of joining the probability is described as significant, moderate, minor or negligible according to paragraph 13 of these rules;
5.3. analysis of any genetically modified organism characteristics that can lead to potential adverse effects, given the genetically modified organisms in the distribution environment, the type and usage. Genetically modified organism characteristics analyzed, showing the following information: 8.5.1. adverse effects of the effects of certain significance-significant, moderate, minor or negligible according to paragraph 13 of these rules;
8.5.2. the harmful effects of probability – the accession a significant, moderate, small or tiny according to paragraph 13 of these rules;
8.5.3. If genetically modified organism properties has more than one adverse effect, any harmful effects of probability and valued separately;
8.5.4. environmental risk assessment methods used in uncertainty:

8.5.4.1. different levels of environmental risk assessment assumptions and extrapolations made;
8.5.4.2. different scientific assessments and viewpoints;
8.5.4.3. inaccuracies;
8.5.4.4. possible derogations from certain restrictions;
8.5.4.5. conclusions made on the basis of existing data;
8.6. the methods of analysis used in the quantitative and qualitative results, the uncertainty and measurement uncertainty. Measurement uncertainty is determined by analyzing: 8.6.1. selection of indicators;
8.6.2. measurements taken;
8.6.3. samples under analysis;
8.6.4. calculation models used;
8.6.5. using causal;
8.6.6. conflicting data or the lack of relevant data;
8.7. the risk management measures and strategy based on genetically modified organism intended form of distribution and use. If the environmental risk assessment is determined genetically modified organism in adverse effects on human and animal health or the environment, the activities envisaged to apply appropriate risk management measures and assess: 8.7.1. dissemination of genetically modified organism and use;
8.7.2. "genetically modified organism (for example, genetically modified micro-organisms, the annual higher plants, perennials higher plants or animals, the genetically modified organisms with one or several types of genetic modification);
8.7.3. normal habitat type (for example, biogeochemical status, climate, of the same species or interspecific intersection probability of origin between different habitats);
8.7.4. agricultural production methods (for example, agriculture, forestry, aquaculture, rural areas, size of sites, varying the number of genetically modified organisms);
8.7.5. natural habitat type (e.g., protected areas in the State). 9. the opinion on genetically modified organism in adverse effects on human and animal health or the environment: 9.1. genetically modified organisms other than higher plants: 9.1.1. the likelihood that the proposed distribution of the genetically modified organism into the environment will become perisitent and invasive in natural habitats;
9.1.2. all positive or negative selective characteristics of the genetically modified organism which is won, and the probability that they may take under the conditions of the proposed release;
9.1.3. information about genetically modified organism: 9.1.3.1. transfer genes to other species;
9.1.3.2. transfer all selective or unfavourable characteristics to other species in the receiving environment;
9.1.4. the probable immediate and delayed adverse effects on the environment resulting from the genetically modified organism directly or indirectly interact with the target organism;
9.1.5. possible immediate and delayed adverse effects on the environment, including competitors, victim symbionts, hosts, predators, parasites, and pathogenic level in the population resulting from the genetically modified organism directly or indirectly interact with the non-target organism;
9.1.6. the probable immediate and delayed adverse effects on human health resulting from the genetically modified organism directly or indirectly interact with the people you work with genetically modified organisms or their distribution;
9.1.7. possible immediate and delayed adverse effects on animal health and consequences of these impacts on the food chain resulting from the use of genetically modified organisms and products derived therefrom, for animal feed;
9.1.8. possible immediate and delayed adverse effects on biogeochemical processes resulting from the genetically modified organism directly or indirectly interact with the non-target organism genetically modified organisms in the distribution environment;
9.1.9. possible immediate and delayed direct and indirect harmful effects on the environment resulting from a particular genetically modified organisms for the risk management measures, if they are different from those which are used for non-genetically modified organism risk management;
9.2. the genetically modified higher plants: 9.2.1. the probability that genetically modified plants in Germany to the highest economic production area will become persistentāk on the recipient or parental plants or more invasive in natural habitats;
9.2.2. all selectively favoured or adverse factors, which are genetically modified higher plant is acquired;
9.2.3. information about genetically modified organism the ability to transfer genes: 9.2.3.1. to other species;
9.2.3.2. transfer all selective or unfavourable characteristics to other species in the receiving environment;
9.2.4. the probable immediate and delayed adverse effects arising from the genetic modification at the highest plant directly or indirectly interact with target organisms (such as predators, parasites and pathogens);
9.2.5. the probable immediate and delayed adverse effects on the environment, including competitors, herbivores, symbionts, parasites and pathogenic level in the population resulting from the genetically modified higher plants directly or indirectly interact with the target and non-target organisms;
9.2.6. the probable immediate and delayed adverse effects on human health arising from the use of genetically modified higher plants directly or indirectly interact with the people who work with the genetically modified higher plants or their distribution;
9.2.7. the probable immediate and delayed adverse effects on animal health and the consequences of the adverse effects on the food chain resulting from the use of genetically modified organisms and products derived therefrom, for animal feed;
9.2.8. possible immediate and delayed adverse effects on biogeochemical processes resulting from the genetically modified organism directly or indirectly interact with the target and non-target organisms in the environment and their distribution;
9.2.9. possible immediate and delayed direct and indirect harmful effects on the environment caused by the particular genetically modified higher plants growing, risk management and harvesting techniques, if they differ from the techniques used in genetically modified higher plants in cultivation. 10. According to the legislation on genetically modified organisms in 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, the person shall draw up a summary of the environmental risk assessment. Summary: 10.1 any genetically modified organism, which can cause possible adverse effects, and the specific significance of adverse effect;
10.2. the possible harmful effects of joining the probability, based on a specific risk of potential adverse effects of the combination, as well as other genetically modified organisms the cumulative effects;
10.3. analysis of the level of uncertainty. IV. Genetically modified organisms harmful impact assessment to determine the 11 genetically modified organism harmful effects, the person assessed and indicates genetically modified organism characteristics, which cause or might cause adverse effects on human and animal health or the environment. The genetically modified organism is harmful effect, if it has, for example, the following characteristics: 11.1. This leads to human, animal and plant diseases, including allergenic or toxic effects;
11.2. it causes impacts on the receiving environment, including protected species, in particular, population dynamics, changes in habitats and genetic diversity of each population;
11.3. it creates a susceptibility to pathogens facilitating the dissemination of infectious diseases or new reservoirs or medium formation;
11.4. This contributes to or initiates a new source of infection, or vector formation;
11.5. it creates a negative impact on the preventive, therapeutic, medical, veterinary, or plant protection (such as gene transfer, causing resistance to medicine or veterinary antibiotics used);
11.6. it produces effects on biogeochemical cycles, particularly carbon and nitrogen circulation that occurs in the soil, organic matter decomposition. 12. Any genetically modified organism in adverse effect describes the specific effects: 12.1. direct effects. It is the primary impact on human and animal health or the environment, which do not arise in the causal event. Direct impact type shall not be regarded, from a target modified genetically modified organism (for example, Bt toxin direct effects on target organisms or genetically modified micro-organism pathogenic effects on human health);
12.2. the indirect impact. It arises from a causal events and activities (for example, the interaction of different organisms, the genetic transfer of genetically modified organism or usage changes, or changes of risk management measures). In the case of a genetically modified organism is detected late effects (for example, if the target insect population decline affects populations of other insects), required to evaluate the risk management measures the harmful effects of such evaluation;

12.3. the immediate effects. The observed distribution of genetically modified organism (for example, insects that feed on the genetically modified plant, which has a resistance to insects, concerned die or people with impaired immunity arises in allergic by contact (exposure) with certain genetically modified organisms). Immediate effects may be direct or indirect;
12.4. the delayed effect. The consequences of such effects are detectable only in the long term, after the distribution of genetically modified organisms in the environment or market launch. It can be both direct and indirect effects (e.g., genetically modified organism characteristics that determine its invasive nature, analyzes several generations or determines the probability that the close affinity of the genetically modified crop hybrids may become invasive in ecosystems). If a genetically modified organism is definitely delayed the risks or adverse effects have not previously carried out research on genetically modified organism delayed effects, provision should be made for specific monitoring of indicator species that contribute to delayed impact and its risk assessment. These effects can be used in determining the appropriate measures (for example, monitoring);
12.5. the cumulative long-term impacts. Genetically modified organisms, the cumulative long-term effects may be assessed if sustained environmental baseline monitoring. The cumulative long-term impact studies include the monitoring of genetically modified organism in the light of the proliferation of genetically modified organism. If genetically modified organism when it is distributed environment or market, is the interaction with people, animals, flora, fauna, soil, or other objects of biodiversity, must be made sensitive to the environmental monitoring of objects. The monitoring of genetically modified organisms, which contain genes that encode resistance to antibiotics or are tolerant to herbicides, as sensitive indicators include micro-organisms, au gus and animals. 13. Genetically modified organisms harmful effects, as determined in accordance with paragraph 12 of these regulations, describes the importance of this harmful effects on human and animal health or the environment. the genetically modified organisms in Particular adverse effect seen in the light of the use of the genetically modified organism and the form of distribution. Contagion effects are broken down into the following: 13.1. significant consequences in the short or long term causes significant changes to one or more species, including endangered and beneficial species. Such changes include a reduction in the number of species or complete destruction, causing negative impacts on ecosystems and other related ecosystems ' functioning. This change is not reversible in the short term, and any ecosystem recovery may be slow;
13.2. the effects of moderate, causing significant changes in population densities of other organisms, but do not cause changes that could lead to the complete destruction of the species or any significant impacts on endangered species or beneficial. About mediocre consequences considered transitory and essential changes in populations where these changes are reversible. Mediocre effect effects can be sustained, if no significant negative impact on ecosystem functioning;
13.3. a small effect that causes significant changes in population densities of other organisms, but causes no other populations or species of organisms to complete destruction, which adversely affected the functioning of the ecosystem. Organisms that might be affected, it may be that the body in the short or long term threats not to belong to species that are not beneficial;
13.4. minimal consequences in any environment or ecosystem populations constitute significant changes. 14. Genetically modified organism characteristics that can cause adverse effects, assessed: 14.1. in relation to human and animal health or the environment, taking account of: 14.1.1. the size of the area in which it is intended to distribute genetically modified organisms;
14.1.2. the genetically modified organisms in the intersection with other organisms outside the distribution environment;
14.2. in relation to the environmental base line. Environmental base line can be affected: 14.2.1 the genetically modified organism in structure;
14.2.2. the nature of the adverse effect;
14.2.3. the spread of genetically modified organisms;
14.2.4. environment for the spread of genetically modified organisms;
14.2.5. the probability of harmful effects of accession;
14.2.6. the distribution conditions;
14.2.7.14.2. these provisions referred to factors. Informative reference to European Union Directive provisions included in the law arising 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. Prime Minister i. Godmanis Minister of Agriculture m. rose