Directive on Risk Assessment Parameters for Modified Organisms No. 05/ 2018”

2. Scope of Application This directive shall be applicable for any transaction of modified organism that has yet not been given an advance informed agreement or special permit by the ministry.

3. General Information 1/ any person who engages in any transaction of modified organisms shall carry out a risk assessment to evaluate possible harm to human or animal health and the environment prior to any activity; 2/ the extent of data or information required may vary depending on whether the transaction is for deliberate release or contained use; 3/ upon decision making, the Ministry shall take into account inclusion of socio- economic considerations. PART TWO

4. Characteristics of Donor and Recipient or Parental Organisms In relation to characteristics of donor and recipient or parental organisms, the following information shall be presented: 1/ scientific name, and when available also common name of the donor gene; 2/ species that are related to and degrees of relatedness; 3/ the degree of relatedness between the donor and recipient or parental organisms; 4/ all the sites from where the donor and recipient organisms were collected, if known; 5/ information on the type of reproduction (sexual/ asexual) of both parental organisms and the length of reproductive cycle and generation time, as well as the formation of resting and survival stages; 6/ history of prior genetic modification, whether and how the donor or recipient organisms were already modified; 7/ phenotypic and genetic markers of interest; 8/ the identification and detection techniques for the organisms, and the sensitivities of these techniques; 9/ geographic distribution and natural habitats of the organisms including information on natural predators, preys, parasites, competitors, symbionts and hosts; 10/ climatic characteristics of their original habitats; 11/ ability of the organisms to survive and colonize the environment to which the release of the modified organism is intended or may accidentally occur; 12/ genetic stability of the organisms, and factors affecting the stability; 13/ the potential of the organisms to transfer to or exchange genes with other organisms, either vertically or horizontally; 14/ pathogenicity to humans or animals, if any; 15/ if pathogenic, their virulence, infectivity, toxicity and modes of transmission; 16/ known allergenicity or toxicity of biochemical or metabolic products; 17/ availability of appropriate therapies for pathogenicity, allergenicity and toxicity. Characteristics of the Vector, Promoter, Terminator and Marker Genes In relation to characteristics of the vector, promoter, terminator and marker genes, the following information shall be provided: 1/ nature and source of the vector; 2/ genetic map of the vector, position of the transgene inserted, other nucleic acid sequences that may affect the expression of traits, marker gene, promoter, terminator that affects trait expression; 3/ ability of the vector to mobilize and transfer other genes that affect trait expression by integration and methods for determining the presence of the vector; 4/ history of prior genetic modification, whether and how the donor or recipient organisms were modified; 5/ potential for human or animal pathogenicity and virulence or allergenicity in humans or animals; 6/ natural host range of vector; 7/ natural habitat and geographic distribution of natural and potential hosts of the vector; 8/ potential impacts of the vector or the inserted transgeneson the environment; 9/ measures for counteracting adverse impacts; 10/ potential to survive and multiply in the environment, or to form genetic recombinants that affect trait expression; 11/ genetic stability of vector, such as hypermutability. Characteristics of Modified Organism In relation to characteristics of modified organism, the following essential information shall be presented: 1/ the description of the modifications; 2/ the function of the modifications including that of each of the transgenes; 3/ the methods for constructing the expression cassette and for introducing it into the recipient organism; 4/ whether the introduced transgene has been integrated or is extra chromosomal; 5/ number of expression transgenes inserted in the host genome, and their structures, for example the copy number and whether in tandem or other types of repeats; 6/ products of the introduced transgenes, in prticular induced trait and levels of expression and methods for measuring expression; 7/ stability of the introduced transgenes that are expressed or not; 8/ biochemical and metabolic differences of the modified organism compared with its unmodified counterpart; 9/ probability of vertical or horizontal gene transfer to other species; 10/ probability of the inserted nucleic acids, transgenes generating pathogenic recombinants with endogenous viruses, plasmids or bacteria; 11/ allergenicities, toxicities, pathogenicities, and other unintended effects; 12/ autecology of the modified organism compared with that of its unmodified counterpart; 13/ susceptibility of the modified organism to diseases and pests compared with its unmodified counterpart; 14/ detailed information on past uses including results of all experiments leading to previous releases. Information on the Modified Organisms With Respect To Safety Considerations For Human And Animal Health In relation to information on modified organisms with respect to safety considerations for human and animal health, the following essential information shall be presented: 1/ capacity for colonization; 2/ if the modified organism is pathogenic to humans or animals the following information is required: a) diseases caused and mechanism of pathogenicity, including virulence; b) communicability; c) infective dose; d) host range and possibilities of using new hosts; e) ability to survive outside of the human or animal host; ) the existence of vectors or other means of transmission; g) biological stability; h) allergenicity, toxicity, pathogenicity and other impacts; i) availability of appropriate therapies. Information on Modified Organisms with r i onsiderations In relation to information on modified organisms with respect to environmental considerations, the following essential information shall be presented: 1/ factors affecting the survival, reproduction and spread of the modified organism in the environment; 2/ techniques for detection, identification and monitoring of the modified organism; 3/ techniques for detecting the transfer of genesfrom the modified organism; 4/ known and predicted habitats of the modified organism; S/ description of the ecosystems which could be affected by accidental release; 6/ possible interactions of the modified organism with other organisms following its accidental release into the environment; 7 known or predicted effects of the modified organism on plants or animals or microorganisms including infectivity, pathogenicity, toxicity, virulence, being a vector of pathogens, allergenicity, colonization or other impacts; 8/ possible involvement in biogeochemical cycles; 9/ methods for decontamination of the area in case of accidental release; 10/ possible impacts on agriculture. Socio-Economic Considerations Essential information related to anticipated socio-economic impacts such as on sustainable agriculture, employment, market opportunities and, in general, conserving and/or enhancing means of livelihood of the communities likely to be affected shall be considered.

10. Effective Date 1 H" , This directive shall enter into force as of the--.- day of 2018 Done at Addis Ababa. 1)6.4.day of,J.C.K/LZOI 8 Dr. Gemedo Dalle MINISTER OF MINSTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE