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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. HJ 625-2011: Guideline for eco-environmental biosafety assessment of Insect-resistant transgenic plants Status: Valid
Basic dataStandard ID: HJ 625-2011 (HJ625-2011)Description (Translated English): Guideline for eco-environmental biosafety assessment of Insect-resistant transgenic plants Sector / Industry: Environmental Protection Industry Standard Classification of Chinese Standard: Z01 Classification of International Standard: 13.020 Word Count Estimation: 12,161 Date of Issue: 2011-09-09 Date of Implementation: 2012-01-01 Quoted Standard: LY/T 1692 Regulation (derived from): Department of Environmental Protection Notice No. 67 of 2011 Issuing agency(ies): Ministry of Ecology and Environment Summary: This standard specifies the insect-resistant transgenic plants impact on non-target organisms, genetic drift, ecological adaptation, target organisms for insect-resistant transgenic plants resistant to the ecological environment of safety testing procedures, contents and methods. This standard applies by expressing insecticidal proteins and traits with insect-resistant transgenic plants new environmental safety testing. HJ 625-2011: Guideline for eco-environmental biosafety assessment of Insect-resistant transgenic plants---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Guideline for eco-environmental biosafety assessment of Insect-resistant transgenic plants People's Republic of China National Environmental Protection Standards Insect-resistant transgenic plant ecological safety testing guidelines (Trial) Guideline for eco-environmental biosafety assessment of Insect-resistant transgenic plants Issued on.2011-09-09 2012-01-01 implementation Issued by the Ministry of Environmental Protection Table of ContentsPreface .II 1. Scope ..1 2 Normative references ..1 3 Terms and Definitions .1 4 Basic principles and procedures 2 5 ecological safety testing background .. 3 Six pairs of non-target organisms affect detection .4 7 gene drift detector 6 8 ecological adaptability detection ..8 9 target organisms to produce insect-resistant transgenic plants resistant safety testing ..9 10 10 Test Report 11 security measures 10 Appendix A (informative) laboratory screening target organisms resistant populations ..11ForewordTo implement the "People's Republic of China Environmental Protection Law", to "the Cartagena Protocol on Biosafety," Assessment and Insect-resistant transgenic plants to control potential environmental risks, protect the ecological environment and biodiversity, development of this standard. This standard specifies the insect-resistant transgenic plant ecological safety testing requirements, the provisions on non-target organisms, group Step by drift, ecological adaptability and insect-resistant target organisms to produce transgenic plants resistant to four ecological safety testing environment And content, developed a corresponding detection methods. Appendix A of this standard is an informative annex. This standard is the first release. This standard is developed by the Ministry of Environmental Protection Science, Technology organization. This standard was drafted. Nanjing Institute of Environmental Sciences Department of Environmental Protection. This standard is approved by the Ministry of Environmental Protection September 9, 2011. This standard since January 1, 2012 implementation. The standard explanation by the Ministry of Environmental Protection. Insect-resistant transgenic plant ecological safety testing guidelines1 ScopeThis standard specifies the insect-resistant transgenic plants on non-target organisms, genetic drift, ecological adaptability, target organisms For insect-resistant transgenic plants resistant to environmental security detection step, contents and methods. This standard applies to eco-environmental safety of transgenic plants expressing insecticidal protein detected by having new insect resistance trait.2 Normative referencesThis standard references the following documents or the terms. For undated references, adapted to their valid version This standard. GB/T 15193 food safety toxicology evaluation procedures and methods NY1101-2006 transgenic plants and their products Food safety assessment guidelines LY/T 1692-2007 revolution and evaluation of forest plant gene product safety technical regulations Transgenic plants and their products environmental safety testing - insect-resistant rice (Ministry of Agriculture Bulletin No. 953 -8-2007) Transgenic plants and their products environmental safety testing - insect-resistant maize (USDA Bulletin No. 953 -10-2007) Transgenic plants and their products environmental safety testing - Cotton Flowers (Ministry of Agriculture Bulletin No. 953 -12-2007)3 Terms and Definitions3.1 insect-resistant transgenic plants insect-resistant transgenic plant By genetic engineering techniques exogenous insect-resistant genes into the plant genome and the expression of insecticidal protein transgenic plant varieties (system). 3.2 parent plant parental plant Accept and express insect-resistant plant varieties exogenous gene (department). 3.3 Transgenic transgene Also called foreign gene or gene variant means by genetic engineering methods and inserted into the genome of the parent plant The exogenous genetic material, including general purpose gene, gene vectors, promoter and terminator gene, a marker gene or reporter gene. Refers to the modification of the gene of the receptor cells express their genetic composition and genetic effects for the purpose of the gene, the purpose of this standard Gene refers to a gene insecticidal protein. 3.4 transgenic protein transgene protein Expression of the gene protein produced in insect-resistant transgenic plants. 3.5 genetic drift gene flow Exogenous insecticidal protein gene from the insect-resistant transgenic plants through pollen to non-transgenic plants or their wild relatives from However, the transfer behavior. 3.6 outcrossing rate of outcrossing rate Insect-resistant transgenic plants and their wild relatives and non-transgenic plants (species) of natural hybridization ratios. 3.7 target species target organisms Insect-resistant transgenic plant transgenic proteins directed to target creature. The standard target gene insect resistant plants Organisms harmful insects means that the target pests. 3.8 Non-target organisms non-target organisms Insect-resistant transgenic plant transit other biological target protein biological gene targeted outside. 3.9 exposure exposure It refers to the insect-resistant transgenic plant components in contact with the non-target organism or circumstances exist simultaneously. 3.10 pest resistant populations resistant pest population Under normal lethal dose an individual to survive and continue normal offspring pest populations. 3.11 Population net added value of net reproductive rate of population Also known as Population trend index, refers to the number under certain conditions, a creature contemporary generation Population Populations on its ratio. 3.12 fitness fitness Individual organisms survive in the ecological environment and the ability of future generations to pass genotype. 3.13 Survival survival competitiveness competitiveness When plants and other plants grow together in community exhibited for the ecological capacity, including seed germination rate, the Seedling rate, growth potential, leaf number and plant height, seed rate, breeding coefficient and other indicators as well as anti-biotic and abiotic stress and other characteristics. 3.14 Weeds potential weediness potential Plant continued ability in artificial communities, including shattering, seed dormancy, from seedlings, seeds and other special survival Sex. 3.15 from volunteer seedlings Plant communities through child really artificial breeding naturally grown seedlings. 3.16 resistance gene frequencies frequency of resistance alleles The proportion of the resistance gene present in the pest population.4 Basic Principles and procedures4.1 Basic Principles 4.1.1 The precautionary principle For insect may cause harm to the ecological environment of transgenic plants, even if it produces the current lack of ecological harm Sufficient scientific evidence, should the transgenic plants were strict ecological safety testing environment and take appropriate advance Preventive measures. 4.1.2 Scientific Principles Ecological safety testing of transgenic insect-resistant plants in the environment must be based on rigorous scientific approach, using the latest science and technology Standards and norms, the collected test data for scientific statistical analysis of test results obtained verifiable and subject Measurement results of scientific explanation. 4.1.3 gradual evaluation principles It should be based on "laboratory studies, intermediate testing, environmental release, production test and commercial production of the" five stages, Gradual development of ecological safety testing insect-resistant transgenic plants under appropriate environmental conditions. 4.1.4 Evaluation Principles Case According to a foreign gene, a receptor plants, genetically modified mode of operation, transgenic plants, environmental release and use different special Points to take the appropriate detection methods, one by one to carry out specific insect resistant genes security research and testing plant, through a comprehensive Comprehensive survey an accurate safety test results. For perennial insect-resistant transgenic plants should generally be carried out on environmental ecological safety after it enters the reproductive phase Testing. 4.2 work program Insect-resistant transgenic plant mainly produces four different ecological environmental risks, should be gradually these four different ecological environment Risks are detected and evaluated (Fig. 1), and give due consideration to the ecological risks to local residents and The possible impact of the economic construction. On non-target organisms Gene drift ecological adaptability 1. The non-target students OK matter 2. confinement Under special detection Given non-target students Movies species groups 3. Opening Under the non-detection Target biota Effect of Falling 1. Determine the target gene drift 2. Get reproductive genetic drift objects Shaped infos 3. Detection of transgenic plants and their wild Relatives of kinship 4. Detection of transgenic plants and genetic drift Target species move between the frequency of gene flow Rate and distance 5. exogenous gene flow of transgenes Like species expression 6. Gene drift ecology of target species Adaptability Evaluation 1. Artificial Ecology Ecological under conformal Testing should be 2. Natural Ecology Ecological under conformal Testing should be Summary of test results, test report issued 1. insect-resistant transgenic plants Was on target organisms Determination of insect resistance 2. The target biological experiments Insect populations transfer chamber Plant resistance genes risk 3. Field-target organisms Natural insect populations Transfer of anti-modified plants Gene frequency monitoring Target organisms transgenic insect Because resistant plants Insect-resistant transgenic plant ecological safety testing Figure 1 insect-resistant transgenic plant environmental safety testing procedures Background information on 5 ecological safety testing 5.1 recipient plant 5.1.1 taxonomic status, including. scientific name, common name and other names; taxonomic status; origin, centers of origin and genetic Biography centers of diversity. 5.1.2 reproductive characteristics, including. reproduction; fertility; under natural conditions with the same or closely related species of outcrossing rate; Hybridization affinity; life history cycle; breeding ability to survive in nature. 5.1.3 genetic stability, ie under natural conditions and other biological possibility of exchange of genetic material, and whether there Genetic variation occurs an adverse effect on human health or ecological data. 5.1.4 environment, including. geographical distribution and natural habitats; ecological environment required for growth and development, and ecological Ecological relationships in the system of other animals, plants and microorganisms, and its potential risk level on the ecological environment. 5.1.5 security application history, including. purpose; domestic applications, including whether there are long-term safety applications Records; on human health and the environment if there have been adversely affected records; if toxic to human and other organisms, should Legend site of toxic substances and their toxic mechanisms exist; recipient plant evolved into harmful plants (eg weeds) possibilities; If the domestic non usually grown plant species (or strains), should provide the plant species (or strains) origin from However, information on its habitat and natural predators, parasites, and co-competitor organisms. 5.2 genetic manipulation 5.2.1 transgenic plants introduced or modified traits and characteristics. 5.2.2 sequences actually inserted, including. the size and structure of the insertion sequence analysis to determine its characteristics; Head Derived gene product expression and biological function; and deduced amino acid sequence of the nucleotide sequence of the gene of interest; Targeting sequence inserted in the plant cells (whether or not integrated into the chromosome, chloroplasts, mitochondria, or in non-integrated form) And determining method; insert copy number sequences. 5.2.3 target gene with a carrier, including. the target gene and vector maps, the name of the carrier, the source node Structure, characteristics and safety, including whether there are pathogenic carrier and the possible evolution of pathogenicity. Promoter and terminator Child size, function and name of the donor organism; the size of the marker gene and reporter gene function and donor organism Title; other expression control sequence name their sources (such as artificial or donor organism name). 5.2.4 expression of the inserted sequences, including. the insertion sequence and expression analysis of the product; in transgenic plants do not With the growth period, the amount of expression of the inserted sequences in roots, stems, leaves, flowers, fruit, seeds and other organs and tissues; expression stability Qualitative. 5.3 insect-resistant transgenic plants 5.3.1 Foreign Genes in Transgenic Plants genetic stability. 5.3.2 Compared with the parent plant, unexpected changes in insect-resistant transgenic plants occur in biological traits like. 5.3.3 Mechanism of insect-resistant transgenic plants and biological characteristics of the target organism target organisms. The method of identification and detection techniques 5.3.4 insect-resistant transgenic plants, as well as the sensitivity and reliability of the technical approach. 5.3.5 Purpose and intended receiving environment geographical, climatic and ecological data. 5.3.6 and abroad about the insect-resistant transgenic plant, or other similar traits turn safety assessment and of the management of genetically modified plants Existing data plane. Detect 6 on non-target organisms affected 6.1 detection step Insect-resistant transgenic plants to detect the impact of non-target organisms are divided into the following three steps. first, through the investigation to determine the need Safety testing of non-target organisms; secondly under confinement detect insect-resistant transgenic plants for a specific non-target organisms Effect; then in an open condition is detected Bacillus thuringiensis transgenic plants on non-target organisms communities. 6.2 non-target organisms is determined 6.2.1 through literature research and field surveys and other means, to identify and classify the lists may be subject to insect-resistant transgenic plants Movies Sound non-target organisms. 6.2.2 according to the following indicators may be affected by the non-target organisms were evaluated and selected through data analysis and expert Feasibility studies, to determine the need for an environmental safety testing or some representative non-target organisms. whether GM Because within the scope of the protein; exposed to the transgenic protein in probability; whether important ecological functions; biological The value of biodiversity conservation, economic and cultural aspects; insect-resistant transgenic plants grown in the place and its surroundings in the Occurrence frequency and abundance. 6.2.3 the need for environmental safety testing of non-target organisms typically cover mammals, birds, fish, aquatic invertebrates Vertebrates, arthropods, soil invertebrates, microorganisms and the like may be the main biological insect resistant genes in plants Groups, especially in China's endemic species. 6.2.4 If you need to detect non-target species as endangered or protected biological, or because the experimental conditions difficult Captive, too little population and other reasons can not meet the testing requirements, you can use other similar biological instead. 6.3 Detection of Bacillus thuringiensis transgenic plants on specific non-target organisms under confinement 6.3.1 Under natural conditions, according to non-target organisms pathway genes in insect resistant plants, manner, time and other factors, provided Meter under closed conditions (laboratory or greenhouse) insect-resistant transgenic plant experiments specific effects on non-target organisms, including poison Pharmacology experiments as well as Predators and parasitoids targeting secondary or tertiary nutrition experiment. 6.3.2 experimental system set up treatment group, negative control group, positive control group and negative control group mortality of non-target organisms Shall not exceed 10%. 6.3.3 using the parent plant or the local ordinary non-transgenic varieties as a negative control, as far as possible in the test genetically modified organisms Protein to carry out the most sensitive life stage test; direct use of insect-resistant transgenic plant material or containing transgenic protein Artificial feeding food test non-target organisms, and exposed to doses higher than the pre-biggest non-target organisms under natural conditions Of exposure dose; duration of the experiment is not lower than the non-target organisms by impacts of genetically modified plants in the natural environment time. 6.3.4 Determination of indicators include indicators of growth and development of non-target organisms (such as mortality, weight, growth, activity Sex), reproductive indexes (such as germ cells and the quantity and quality of offspring) and important ecological function indicators. 6.3.5 If the insect-resistant transgenic plants have a significant effect on specific non-target organisms, further testing should produce this remarkable Movies Ring the minimum required exposure dose, clear this significantly affect the insect resistant-related genes between plants and open bar Member under investigation specific non-target organisms for insect-resistant transgenic plants actual exposure dose, and at this dose non-target organisms Affected. 6.4 Detection of Bacillus thuringiensis transgenic plants on non-target organisms in the community under open conditions 6.4.1 In order to verify the conditions under confinement insect-resistant transgenic plant test results for a specific non-target organisms, detecting insect-resistant transgenic Due to the impact of plants on other non-target organisms, should be tested for insect-resistant transgenic plants under open conditions farmland, forest, water, etc. Its impact was debris on non-target organisms communities. 6.4.2 objects to be detected growing insect-resistant transgenic plant site and its surroundings may be the impact of non-target students , Particularly a part of the test results showed that 6.3 may be significantly adversely affect non-target organisms. mainly include. (1) the impact on the ground some non-target organisms communities, including non-target pests and natural enemies in biological and related move And plants, etc., especially important harmful or beneficial organisms. (2) the impact on soil and water ecosystems in Central Africa target biological communities, including non-target microorganisms, invertebrates Vertebrates, invertebrates, especially important harmful or beneficial organisms. 6.4.3 testing include. the number of plants and their survey of non-target species population dynamics of insect-resistant transgenic control experiment Tanaka Changes ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of HJ 625-2011_English be delivered?Answer: Upon your order, we will start to translate HJ 625-2011_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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