PLANT BIOTECHNOLOGY AND BIOSAFETY - A. P. Ermishin - 2015

APPENDIX

Class="center">Information checklist on risk assessment of potential Adverse effects of genetically engineered organisms belonging to higher plants (gymnosperms and angiosperms) on human health and the environment, as well as risk Prevention measures (in accordance with the Regulations on the Procedure for State Expertise of the Safety of Genetically Engineered Organisms and Model Terms of Contracts Concluded for its Conduct, Resolution of the Council of Ministers of the Republic of Belarus No. 1160 of September 8, 2006)

1. Information on the Biological features of the recipient Organism:

1.1. full Taxonomy: family, genus, species, subspecies, variety/breeding line, common name;

1.2. reproduction-related information: mode(s) of reproduction, specific factors influencing reproduction, timing of progeny production, sexual compatibility with other cultivated or wild species;

1.3. environmental survival: ability to form survival structures or enter a dormant state, specific factors affecting survival;

1.4. dissemination: pathways and extent of dissemination, specific factors influencing dissemination;

1.5. geographical distribution;

1.6. description of natural habitats, including information on natural predators, parasites, competitors, and symbionts;

1.7. potentially significant interactions with non-plant organisms in ecosystems typical for normal growth, including information on toxicity to humans, animals, or other organisms.

2. Information on the biological features of donor organisms:

2.1. full taxonomy: family, genus, species, subspecies, variety/breed/strain, common name;

2.2. origin of donor organisms;

2.3. biological characteristics of donor organisms.

3. Biological Features of the vector:

3.1. nature and Water/144.html">Origin of the vector, natural habitat, and relevant safety characteristics;

3.2. Structure of Transposons, promoters, and other non-coding genetic segments used to construct the genetic construct required for its transfer and functioning in the recipient organism;

3.3. mobilization frequency (ability to acquire mobility) of the inserted vector or its transfer to other organisms;

3.4. factors that may affect the ability of the vector to adapt in other host organisms.

4. Information relating to The Nature of the Introduction/32.html">Genetic Engineering modification:

4.1. Methods used for the creation, transfer of the transgenic construct, and Selection of transgenic organisms;

4.2. Description of the DNA fragment integrated into The Genome (plasmon) of the recipient organism (size and source, i.e., name of the donor organism(s) and putative function of each component or region of the inserted DNA, including regulatory and other elements affecting transgene function), structure (sequence) and functional integrity of the inserted DNA fragment, and the presence of any known potentially hazardous sequences therein;

4.3. presence of any unknown sequences in the inserted DNA and information on the extent to which the insertion is restricted to the DNA required to achieve the intended function;

4.4. characterization of the modification site in the recipient genome (plasmon), localization of the insert (whether incorporated into a chromosome, METABOLISM/14.html">Chloroplasts, or Cell/35.html">Mitochondria, or present in an unintegrated state);

4.5. the stability of incorporation of the introduced DNA into the genome (plasmon) of the recipient organism;

4.6. the copy number of the transgenes;

4.7. a description of the methodology for detecting and identifying the inserted DNA fragment, along with its sensitivity, reliability, and Specificity.

5. Information regarding the biological characteristics of genetically engineered organisms:

5.1. a description of genetic traits or phenotypic characteristics, particularly any novel traits and characteristics that have emerged or been suppressed in the genetically engineered organisms compared to the recipient organism;

5.2. the genetic Stability of the genetically engineered organisms;

5.3. the extent and level of transgene expression, including the method used to assess transgene expression and its sensitivity;

5.4. the activity and Properties of the protein(s) encoded by the transgene(s);

5.5. the plant parts in which the transgenes are expressed (roots, leaves, pollen, etc.);

5.6. The history of previous genetic modifications of the genetically engineered organisms;

5.7. the characterization of the genetically engineered organisms with respect to human health safety: toxic or allergenic effects of the genetically engineered organisms and/or products derived from them;

5.8. proposed methods for detecting and identifying the genetically engineered organisms, including their accuracy, sensitivity, and reliability.

6. Information concerning the potential receiving environment:

6.1. the Location OF THE release site (region, district, settlement, landownership or land-use affiliation with the full name of the owner or user);

6.2. proximity to nature reserves, sanctuaries, and other protected natural areas and objects;

6.3. a description of the site: size and management status, climatic, geological, and pedological characteristics, as well as flora and fauna;

6.4. a comparison of the natural habitats of the recipient organisms with the intended release site of the genetically engineered organisms;

6.5. methods of environmental intervention at the site (cultivation, irrigation methods, etc.).

7. Information on the interaction of genetically engineered organisms with the environment:

7.1. the biological CHARACTERISTICS OF THE genetically engineered organisms (compared to intact recipient organisms) that may influence their survival, reproduction, and dissemination in the potential receiving environment;

7.2. known and predicted conditions of the potential receiving environment that may affect the survival, reproduction, or dispersal of the genetically engineered organisms;

7.3. the competitive advantage of the genetically engineered organisms (compared to intact recipient organisms);

7.4. the likelihood of the genetically engineered organisms expressing undesirable traits or properties in the potential receiving environment;

7.5. the probability of a sudden population surge of the genetically engineered organisms in the potential receiving environment;

7.6. the capacity for Genetic information transfer: the presence in the potential receiving environment of wild or cultivated related species capable of hybridizing with the genetically engineered organisms, and the probability of transgene transfer from the genetically engineered organisms to such organisms;

7.7. identification and description of target organisms of transgene products;

7.8. anticipated mechanism and outcome of interaction between genetically engineered organisms and target organisms;

7.9. identification and description of non-target organisms of transgene products that may be affected by genetically engineered organisms;

7.10. other potential environmental interactions of genetically engineered organisms;

7.11. information concerning the intended use of genetically engineered organisms, including any new or modified use compared to the recipient organism.

8. Information concerning the deliberate release of genetically engineered organisms into the environment, monitoring, control, site remediation, and emergency response measures during release and testing:

8.1. information on the release of genetically engineered organisms: a description of the proposed release process and its purpose; anticipated start and end dates of the release, along with a schedule of release-related experiments, including the number and duration of experiments; the estimated quantity of released genetically engineered organisms, and the density of genetically engineered organisms per unit area; the distance from the site to plantings of wild and cultivated related species capable of hybridizing with the genetically engineered organisms; information on the availability and results of previous environmental releases of genetically engineered organisms;

8.2. monitoring methods: Procedures for observing genetically engineered organisms and monitoring their potential interactions with vulnerable environmental elements; specificity, i.e., The ability to identify genetically engineered organisms and distinguish them from recipient organisms, as well as the sensitivity and reliability of monitoring methods for genetically engineered organisms; methods for detecting transgene transfer to other organisms; duration and frequency of monitoring;

8.3. control of the release of genetically engineered organisms: measures intended to prevent the dispersal of pollen and seeds of genetically engineered organisms; methods and procedures designed to secure the release site against unauthorized access; methods and procedures to protect the site from unwanted visits by other organisms;

8.4. site remediation: site Treatment procedures upon completion of the release; methods for removing genetically engineered organisms after the experiments are concluded;

8.5. emergency response plan for accidental dissemination of genetically engineered organisms: methods and procedures for controlling genetically engineered organisms in the event of unintended dispersal; Methods for the disposal or remediation of plants, animals, etc., that may have been exposed to genetically engineered organisms during or after their accidental spread; contingency plans for human health and environmental protection in the event of adverse effects from genetically engineered organisms.