Resolution No. 382 of the Council of Ministers “On risk assessment in genetic engineering activities and issuance of a permit.”

Regulation on the procedure for assessing the risks of possible harmful effects of genetically engineered organisms on human health and the environment determines the procedure for conducting risk assessment on the basis of an application from a legal entity or individual entrepreneur who is the initiator of its implementation to one of the organizations authorized to conduct risk assessment of possible harmful effects of genetically engineered organisms on human health and the environment, the list of which is determined by the Resolution approving this Regulation. The interested party cannot act as an authorized organization. The authorized organization, within 30 days from the date of application and submission of the necessary samples and materials from the interested party, enters into an agreement with him to conduct risk assessment of the possible harmful effects of genetically engineered organisms on human health and the environment. Risk assessment is carried out within 120 days from the date of conclusion of the contract. When conducting risk assessment, in cases where it is impossible to assess the acceptability of the risk of possible harmful effects of genetically engineered organisms on the environment or human health, the authorized organization may request additional information about the genetically engineered organisms from the interested party. The interested party is obliged to provide specialists of the authorized organization with access to samples of genetically engineered organisms to conduct risk assessment. Based on the results of the risk assessment, the authorized organization draws up a report containing conclusions about the admissibility (inadmissibility) of the release of genetically engineered organisms into the environment for testing or use for economic purposes, and issues it to the interested party. The specified report is open-ended (unlimited).
Regulation on the procedure and conditions for issuing permits for the release of non-pathogenic genetically engineered organisms into the environment for testing establishes that release of non-pathogenic genetically engineered organisms into the environment for testing is carried out on the basis of a permit issued by the Ministry of Natural Resources and Environmental Protection. The permit is issued with the consideration of the recommendations of the expert council on the safety of genetically engineered organisms sub ordinate to the Ministry of Natural Resources and Environmental Protection on the admissibility of release of non-pathogenic genetically engineered organisms into the environment for testing. To obtain permission to release non-pathogenic genetically engineered organisms into the environment for testing, a legal entity or an individual entrepreneur submits an application to the Ministry of Natural Resources according to the form contained in the Appendix 1 and other documents provided for in paragraph 6.36 of the uniform list of administrative procedures carried out by government bodies and other organizations in relation to legal entities and individual entrepreneurs. The permit is signed by the Minister of Natural Resources and Environmental Protection or his deputy.