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Risk assessment
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 Principles of the environmental risk assessment study

A. Objective

Objective assessment of environmental risk (ERM) is the identification and assessment of potential negative effects of genetically modified organism (GMO) may have on human health or on the environment during introduction into the environment or market, effects which can be direct or indirect and can occur immediately or delayed. ERM should be conducted to establish whether or not, to develop a risk management plan and where it is necessary, be given the best way to implement it.

B. General rules

In line with the precautionary principle in achieving the study of environmental risk assessment must contain the following general rules:

1. Identified characteristics of GMOs, which can generate negative effects during its use must be compared with characteristics of non-GM, from which, and for similar uses.

2. The study of environmental risk assessment should be done in a scientific and transparent manner based on existing data.

3. Risk assessment study conducted for each case as information may vary depending on the type of genetically modified organism, the intended use and the environmental characteristics of introduction. Taking into account inter alia of the results of previous introductions of genetically modified organism into the environment.

4. When new information on genetically modified organism and its effects on the environment, the study of environmental risk assessment should be reviewed to determine whether:

a) risks change;
b) be amended risk management plan.

C. Methodology

C.1. The characteristics of genetically modified organisms and the environment in which they are introduced

In the case study should take account of existing technical and scientific information that relates to:
1. body (bodies) parental or receiver;
2. changes (changes) gene obtained by insertion or deletion of genetic material, and relevant information about Vector and donor;
3. Genetically modified organism;
4. introduction or proposed use, including the scale of the work performed;
5. potential receiving environment;
6. interaction between them.

Information about the similar bodies of organisms with similar features can be considered in the study of environmental risk assessment.

C.2. Steps study environmental risk assessment

Opinion survey of risk assessment to refer to the following:

1. Identifying characteristics that may cause adverse effects
Any characteristics of genetically modified organisms due to these genetic changes, which may adversely affect human health or the environment must be identified. This is necessary to consider the comparison with the genetically modified organism characteristics of non-modified organism under similar conditions. It is important not to omit any analysis of a possible negative effect on the consideration that its occurrence is unlikely.
Potential adverse effects of GMOs will vary from case to case and may include:
- Disease of humans, including effects of allergenicity or toxicity;
- Disease of animals and plants including toxic effects and, where appropriate, of allergenicity;
- Effects on population dynamics of species in the receiving environment and genetic diversity of each of these populations,
- A possible modification of pathogenic agents that could facilitate transmission of infectious diseases and / or development of new sources or vectors pathogens;
- Compromising prophylactic or therapeutic action of some treatments, such as, for example, transfer of genes that confer resistance to antibiotics used in veterinary medicine;
- Effects on biogeochemical flows, especially carbon and nitrogen circuits by altering the capacity of soil to decompose organic matter.
The negative effects may arise directly or indirectly, through various ways such as:
- Spread of modified organisms into the environment;
- Transfer of inserted genetic material to other organisms or the same type of body, but GM;
- Genetic and phenotypic instability;
- Interaction with other organisms;
- Change management, including, where appropriate agricultural practices.

2. Evaluation of the possible consequences of adverse effects
Amplitude should be evaluated possible negative consequences of each. This evaluation should be made for each adverse effect and consider the consequences of that magnitude may be influenced by the environment is the introduction of genetically modified organism and how to make this introduction.

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