Ukraine legally establishes criteria for risk assessment for environmental release of GMO’s

On March 14th, the order of Ministry of Environment and Natural Resources of Ukraine N36 from February 7, 2011 entered into force, which approved the criteria for risk assessment of the potential impact of GMOs on the environment. The relevant order is registered in the Ministry of Justice on March 1, 2011 under N247/18985.
 
Provisional translation
 
CRITERIA of risk assessment of potential impacts of genetically modified organisms on the environment
 
1. These criteria are designed to determine the impact assessment on the environment of genetically modified organisms (hereinafter - GMOs) and their metabolites, taking into account the impact of methods and tools throughout the production cycle of their use, the possibility of scale effects and the likely environmental impact of GMO being handling in open systems basing on independent experimental studies and reliable data derived by those studies of an impact of each specific GMO, its intended use and the likely potential receiving environment.
 
2. Information needed to assess environmental risks associated with the release of genetically modified organism into an open system to the state (trials), and the requirement to assess risk to the environment through exposure to genetically modified organism are given in Annex 2 to the “Order of authorization for the state testing ( testing) of genetically modified organisms in an open system”, approved by the Cabinet of Ministers of Ukraine dated 02.04.2009 N 308.
 
3. Risk of the potential impact of GMOs on the environment is assessed through the following criteria:
 
3.1. Security and stability (phenotypic and genotypic) of GMO and its progenies, factors that affect them, likelihood of unforeseen effects and properties that are caused by genetic modification.
 
3.2. Safety of GMOs to the environment, including effects on biochemical and biogeochemical cycles in the process of decomposition of organic material in soil.
 
3.3. GMO safety for animals including possible immediate and/or remote effect on animal health and consequences for the trophic chain through the use of GMOs.
 
3.4. Impact of GMOs on populations dynamics of species released into the environment and genetic diversity in each of the species, including impact on non-target organisms for at least three generations.
 
3.5. Knowledge about interaction between GMOs and the environment and the impact of GMOs on the ecosystem in which release is planned.
 
3.6. Availability of methods and techniques for identifying GMOs developed under international standards and legally approved Ukraine, as well as methods for GMOs detection and identification GMOs in the environment.
 
3.7. Existence of instructions and manuals on the use of GMOs and methods that ensure biological and genetic safety during their production cycle, processing, storage, transportation, disposal, destruction and disposal
 
3.8. Availability of plans for preventive measures and removal, and environmental protection in the event of an emergency due to unintended release of GMOs into the environment, measures to detect undesirable effects of GMOs.