The Risk assessment

Commencement of any operation consisting on the deliberate release of GMOs into the environment, including placing of GMO products on the market, shall require risk assessment of human health and environmental to be carried out, as well as application of measures to avoid these risks.

Particular safety measures shall be required for GMOs containing resistance genes to antibiotics used in the treatment of human beings and animals.

The risk assessment shall be carried out in a manner verifiable against available scientific and technical data given direct and indirect risks, which may occur in the short- and long-term.

The following actions shall be carried out during risk assessment of deliberate release of GMOs into the environment including placing of GMOs products on the market:

• identify traits or method of GMO use which may cause adverse effects and compare them with traits of a non-modified organism and its use in similar conditions,
• assess potential effects of each pathogenic effect given features of the environment which the GMO is released into and the method of release,
• assess the likelihood of occurrence of potential effects,
• define methods of counteracting risk and potential effects thereof.

The risk assessment shall include data regarding:

• the benefits from the deliberate release of GMOs into the environment and the likelihood of such benefits arising under the conditions of the activities proposed,
• its adverse effects and the risks it may present to farming, including farming by organic methods.

In carrying out the risk assessment, it shall be necessary to:

• identify all the characteristics of GMOs related to the genetic modification which may cause adverse effects on human health and the environment,
• take into account the fact that the scope of indispensable information needed for carrying out the assessment depends on the GMOs, their use and the potential environment where they are to be used, including their effects on the agricultural production area.

In order to identify the characteristics of GMOs related to the genetic modification, which may cause adverse effects on human health and the environment it shall be necessary to compare the characteristics of GMOs with those of a non-modified organism which is used under similar conditions.

The risk assessment shall take into account technical and scientific information regarding:

• the recipient or the parental organism,
• the character of the genetic modification as well as information on the vector and the donor,
• the scale of the deliberate release of GMOs into the environment,
• the environment into which the deliberate release is to take place and the interactions between the environment and GMOs.

In carrying out the risk assessment, the likelihood of the following effects shall be considered:

• the spread of GMOs in the environment,
• the transfer of the genetic material introduced to other organisms or specimens of the same species,
• the phenotypic or genetic instability of GMOs,
• change in relations with other organisms,
• changes in the economy, in particular in farming, veterinary and forest-management activities.

Information on genetically non-modified organisms with characteristics similar to those of GMOs and information on their effects on the environment resembling the one into which the deliberate release is to be made shall be enclosed with the risk assessment.

When carrying out the risk assessment, all the characteristics of GMOs related to the genetic modification, which may cause potentially adverse effects on human health or the environment shall be identified.

The potentially adverse effects referred shall include:

• human contagious diseases as well as allergic symptoms and toxic effects,
• diseases caused in animals and plants, including their toxicity and – where they may arise – allergic symptoms,
• the effects on the population of organisms present in a given environment and their genetic diversity,
• change in vulnerability to pathogens which facilitate the dissemination of contagious diseases or the establishment of new foci of diseases or vectors,
• a reduction in the effectiveness of prophylactic or therapeutic measures applied in the medical and veterinary fields as well as in plant breeding and protection, caused, inter alia, by transfer of genes conferring resistance to antibiotics used in the therapy of humans and animals,
• the potential for uncontrolled spread of GMOs to the areas of crops cultivated by organic methods,
• the effects on biogeochemical cycles, including the carbon and nitrogen cycles, as a result of change in the decomposition of organic matter in soil,
• other quantitative and qualitative changes observed in the environment.

When identifying the characteristics, which may have potentially adverse effects on human health or the environment, it shall be necessary to present:

• the estimated scale and an assessment of the results of the potentially adverse effects,
• the likelihood of the emergence of each potentially adverse effect depending on the environment into which GMOs are to be released and the manner of the release,
• an assessment of the risk posed by each trait of GMOs,
• the measures to prevent the risks and their potentially adverse effects caused by the deliberate release into the environment, including placing on the market.

On the basis of the prepared risk assessment, taking into account the conditions of deliberate release of GMOs into the environment it is necessary to formulate conclusions regarding to:

• the likelihood that a GMO may become a permanent and invasive species in the natural environment or that it may initiate new processes to disrupt the processes which are in a state of equilibrium,
• change in the competitiveness of GMOs with respect to non-modified recipients or parental organisms and the likelihood of its emergence,
• the potential for the transfer of genes to other species and change in the competitiveness of these species,
• the expected effects on the target organisms in the environment,
• change in competitiveness with respect to:
  • hosts,
  • symbionts,
  • predators,
  • parasites,
  • pathogens,
• the expected effects on the environment caused by the interactions between GMOs and the non-target organisms,
• the potential effects on human health caused by the interactions between a GMO and persons in contact with the GMO or present in its vicinity,
• the potential effects on the health of animals from which products intended for human consumption are obtained,
• the potential effects on crops cultivated by organic methods,
• the known or expected involvement in biogeochemical processes,
• the potential effects on the environment related to specific techniques applied in GMO-related activities,
• other significant effects on human health and the environment.