Directive to Determine the Content of an Application for Undertaking Transaction Involving Deliberate Release of Modified Organisms No. 08 /2018

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1 — Short Titl

1. Short Titl This directive may be cited as the “Directive to Determine the Content of an Application for Undertaking Transaction Involving Deliberate Release of Modified Organisms No. 28 /20187, 2. f Application This directive shall be applicable to an application submitted to engage in transaction for introduction into the environment of any modified organism for which no specific containment measures are used to limit their contact with the environment.

3 — General information

3. General information The application for undertaking transactions involving deliberate release of modified organisms shall contain the following general information: 1/ name, address and contact details of applicant; 2/ name and field of studies of persons responsible for planning and carrying out the implementation of the project, including those responsible for supervision, monitoring and safety, in particular the name of the responsible scientist. PART TWO INFORMATION ON DONOR, RECIPIENT AND THE MODIFIED ORGANISM De: iption of Donor, ipient he Modifi rganis With regard to donor, recipient and modified organisms, the following information shall be presented by an applicant: 1/ scientific name, and when available also common name of the donor organism; 2/ scientific name, and when available also common name of the recipient modified organism; 3/ scientific names, and when available also common names, of species that are related to any of the organisms from which any of the trans-genes in the expression cassette have been taken; 4/ degree of relatedness between the donor and recipient (between parental) organisms; 5/ description of the geographic distribution and of the natural habitats of the donor and recipient (between parental) organisms; the environments where they occur. C eristi clei ids th trai ressio With regard to characteristics of nucleic acids that affect trait expression the following information shall be presented by the applicant: 1/ description of each expression cassette; 2/ whether the nucleic acid that affects trait expression is introduced without change or has been modified; if modified, methods used to modify the nucleic acid composition; 3/ nucleic acid sequence of, inter alia, the target gene, promoter, terminator and selectable marker; 4/ description of the trait that it expresses 5/ methods used to construct the expression cassette; 6/ genetic markers; 7/ description of identification and detection techniques of the nucleic acids; 8/ quantitative expression of sensitivity, reliability and specificity of the identification and detection techniques; 9/ potential for nucleic acids involved in trait expression being transferred to or exchanged with other organisms; 10/ verification of the stability of the nucleic acids and factors affecting their stability. Characteristics of the Vector With regard to characteristics of the vector the following information shall be presented by the applicant: 1/ nature and source of the vector; 2/ sequence of the non-coding genetic segments used to construct the expression cassette and to introduce it into the recepient organism to produce the modified organism; Characteristics of the Modified Organism With regard to characteristics of the modified organism the following information shall be presented by the applicant: 1/ Information relating to the modification: a) Methods used to introduce the inserts into the recipient organism; b) Copy number of the insert; ¢) Presence of any vector backbone including its sequence; d) Sequence, functional identity and location of the altered or inserted or deleted nucleic acid with particular reference to any known harmful sequence; 2/ Information on the modified organism: a) Unique identifier of the transformation event ; b) Description of phenotypic characteristics and in particular any new traits and characteristics which may be expressed or may no longer be expressed; c) Stability of the traits; d) Expression of the introduced new genetic material and methods and sensitivity of measurement; e) Function of the expressed protein; ) Sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques of the modified organism; g) History of previous releases or uses of the modified organism; h) Risks to human or animal health, biological diversity and the environment; i) Generation time in natural ecosystems, sexual and asexual reproductive cycles; 7 Information on survival, including seasonality and the ability to form seeds, spores, sclortia and other survival structures; k) Pathogenicity, infectivity, toxicity, virulence, allergenicity, ability to be a carrier (vector) of pathogens, identity of possible vectors to transimit it to humans or animals as a disease causing agent, host range, possible activation of latent viruses, ability to colonize other organisms, ability of nucleic acids or other molecules that affect trait expression to be introduced into the cells or tissues of other species; 1) Antibiotic resistance, and potential use of these antibiotics in humans or domestic animals for prophylaxis or therapy; m) Involvement in environmental processes, primary production, nutrient cycling, decomposition of organic matter and other activities; n) Risk of passing modification to other organisms; 3/ Considerations of impacts on health: a) Toxic, allergenic, or other similar effects of the modified organism on humans or animals; b) Comparison of the modified organism with the donor and recipient or unmodified parental organisms regarding pathogenicity, allergencity, or other similar effects in humans or animals; c) Capacity for colonization; d) If the organism is pathogenic or toxic or allergenic to immunocompetent humans or animal, the following information is required: 1) diseases caused and mechanism of pathogenicity including invasiveness and virulence; 2) communicability; 3) infective dose; “) host range and possibility of alteration of hosts; 5) possibility of survival outside of humans or other organisms; (6) vectors or means of dissemination; 7 biological stability; ®) availability of appropriate therapies. PART THREE INFORMATION RELATING TO THE RECEIVING ENVIRONMENT AND INTERACTION BETWEEN THE MODIFIED ORGANISM AND THE RECEIVING ENVIRONMENT

8 — Information

8. Information on the Deliberate Release With regards to the release the following information shall be presented by the applicant: description of the proposed deliberate release, including the purpose and foreseen outcome; planned dates and durations of the release; method to be used for the release; quantity of modified organism to be released; site preparation prior to release (type and method of cultivation, mining, irrigation, or other activities); information on, and results of, previous releases of the modified organism especially at different scales and in different ecosystems. S ultiplication. di 1 and trait ex; ion With regard to survival, multiplication, dispersal and trait expression the following information shall be presented by the applicant: 1/ biological features which affect the survival, multiplication and dispersal of the modified organism; 2/ known or predicted environmental conditions which may affect the survival, multiplication and dispersal (wind, water, soil, temperature, pH, pollutants such as pesticides, heavy metals, horizontal gene transfer and others) of the modified organism or of its genes or other biochemicals that affect trait expression.

10 — Interactions with the environment

10. Interactions with the environment In relation to interaction with the invironment the following information shall be presented by the applicant: 1/ habitat types expected to be suitable for the modified organism; 2/ experiments carried out on the behaviour of the modified organism and an assessment of its ecological impact carried out in simulated natural environments, such as growth rooms and greenhouses; 3/ trait transfer capability: a) possibility for post-release transfer of inserted genetic materials from the modified organism into organisms in the ecosystem; b) possibility for post-release transfer of genetic material from organisms in the ecosystem to the released modified organism; 4/ likelihood of post-release interaction leading to the expression of unexpected or undesirable traits in the modified organism or in its products; 5/ measures employed to ensure and verify genetic stability; description of genetic traits which may prevent the transfer of genetic materials; methods used to verify stability; 6/ routes of biological dispersal of the modified organism, known or potential modes of interaction with the disseminating agents, including dispersal by wind, water, inhalation, ingestion, surface contact with or burrowing into animals, and others; 7/ description of ecosystem to which the modified organism could be disseminated.

11 — Potential environmental impacts

11. Potential environmental impacts In relation to potential environmental impact the following information shall be presented by the applicant: 1/ potential for excessive population increase of the modified organism in the environment; 2/ competitive advantage of the modified organism in relation to the unmodified or parental species; 3/ identification and description of the target species that are anticipated to be affected by the modified organism; 4/ anticipated mechanism and result of interaction between the released modified organism and the target species; 5/ identification and description of non-target species which may be affected; 6/ likelihood of post-release shifts in biological or in target range; 7/ known or predicted effects on population levels of competitors, preys, hosts, symbionts, predators, parasites and pathogens; 8/ known or predicted involvement of the modified organism in biogeochemical processes; 9/ other potentially significant interactions with the environment.

12 — Information on monitoring and monitoring techniques

12. Information on monitoring and monitoring techniques With regard to monitoring and monitoring techniques the following information shall be presented by the applicant: 1/ methods for tracing the modified organism and for monitoring its effects; specificity, sensitivity and reliability of the monitoring techniques to identify the modified organism; techniques for detecting the transfer of the introduced transgene to other organisms; 4/ methods for detecting aberrant expression of traits and their causes. PART FOUR ADDITIONAL INFORMATION REQUIRED FOR PLACING ON A MARKET A OMMODITY ISTIN: F A MODIFIED ORGAN 13. nformation requi where the transaction rel. to an lication for placing a modified organism on a market With regard to transaction relating to an application for placing a modified organism on a market, the following additional information, where relevant, shall be presented by the applicant: 1/ name of the commodity, the scientific and common names and the transformation event of the modified organism; 2/ names and addresses, including telephone numbers and e-mails, of the maker and the distributor of the modified organism; 3/ specification for accessing information on the modified organism in the Biosafety Clearing House of the Protocol; 4/ type of expected use; 5/ specific instructions for storage and handling.

14 — Information required where the transaction relates to the placing of modified

14. Information required where the transaction relates to the placing of modified organism as food on the market With regard to the transaction relating to the placing of modified organism as food on a market, the following additional information, where relevant, shall be presented by the applicant: 1/ equivalence studies; 2/ information on antibiotic resistance marker genes (if used); 3/ characterization of novel proteins or other novel substances which includes information about prior history of human consumption of the novel substances if any, or their similarity to substances previously consumed in food; 4/ the potential toxicity of novel proteins produced by the modified organisms; 5/ the potential allergenicity of novel proteins; 6/ compositional analysis of the modified organism as food or food derived from a modified organism; 7/ data to allow the nutritional impact of compositional changes in the food to be assessed; 8 data from animal feeding study; 9/ name the food will be marketed under.

15 — Information required where the transaction relates to the placing of the modified

15. Information required where the transaction relates to the placing of the modified nism d on the market With regard to the transaction relating to the placing of the modified organism as feed on the market, the following additional information, where relevant, shall be provided by the applicant: 1/ the potential for adverse health effects to humans and livestock, including exposure to toxins and anti-nutritional factors, as well as irritation and allergenicity to humans; 2/ the potential to carry over of any novel product to manure and the potential impact of this to carry over; 3/ nutritional data which includes a comparison of the composition of the novel feed ingredient to that of the same feed ingredient derived from an appropriate counterpart; 4/ dietary exposure; 5/ toxicology data such as endogenous toxins or newly expressed material; 6/ allergenicity data; 7 laboratory animal/livestock feeding trials.

16 — Information required e the transaction relates t ac ontaining the

16. Information required e the transaction relates t ac ontaining the modified organism 1/ With regard to the transaction relating to the package containing the modified organism, the applicant shall affix and show the following information on the package containing the modified organisms: a) names and addresses including telephone number and e-mail of sender and reciever of the modified organisms; b) the phrase "contains modified organisms” shall be written on the label in Amharic and English laguage whenever it is known that there is modified organism in the package. 2/ The phrase “Contains no modified organisms™ may be written in Amharic and English on the label when the product is known to contain no modified organism.

17 — Effective Date e /D/

17. Effective Date e /D/ This directive shall enter into force as of the---! day of 2018 Dr. Gemedo Dalle MINISTER OF MINSTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE