The Ministry of Agriculture decided to "genetically modified organisms safety evaluation management approach" be amended as follows:

First, the Article 5 is amended as: establishment of a national agricultural genetically modified organisms, "according to" the provisions of Article IX of the Ordinance " safety Committee, responsible for the safety evaluation of agricultural genetically modified organisms GMOs national security committee in terms of genetically modified organisms in research, production, processing, inspection and quarantine, sanitation and environmental protection experts, term of five years ".. | ||
Second, Article 6 shall be amended as: "agricultural genetically modified organisms in research and testing organization is primarily responsible for the safety management of agricultural genetically modified organisms, genetically modified organisms safety team should be formed by the unit in charge of the legal representative responsible for reviewing the work of the unit safety management and safety evaluation of agricultural genetically modified organisms declared "added as the second paragraph:." agricultural genetically modified organisms in research and testing units, test procedures should be developed genetically modified organisms, strengthen agricultural genetically modified biological tests can be traced back management "

Third, the sixteenth amended as follows:" the Ministry of agriculture shall accept genetically modified organisms safety evaluation of the application of the application is accepted, shall be made by the State Agricultural GM Crop Biosafety Committee. safety evaluation. national genetically modified organisms safety committee at least twice a year to carry out genetically modified organisms safety assessment. to approval in accordance with the "People's Republic of China Administrative Licensing Law" and "regulations" of the Ministry of agriculture, after receiving the results of the safety evaluation. "|| |
IV Article XVII delete items, the fourth modified to third.

Fifth, the second paragraph of Article 22 "of the test unit made in the preceding paragraph apply, shall provide the following material" was changed to: "the test unit made in the preceding paragraph apply, shall be in accordance with relevant Security Evaluation Guide the requirement to provide the following materials. " Added as the third paragraph: "Application Production test shall also be required to submit GMOs samples, control samples and test methods."

Six in Article 22 is added after: "in the genetically modified organisms safety approval for the validity of the test units need to change the location of the test, shall report to the genetically modified organisms safety management office."

seven, the first paragraph of Article 23 is amended as: "after the end of the test intends to apply for genetically modified organisms safety certificate, the test unit shall apply to genetically modified organisms safety management office, the national agricultural genetically modified organisms safety committee qualified safety evaluation by the Ministry of agriculture approved before issuing agricultural GMOs safety certificate "the second paragraph" the test unit made in the preceding paragraph apply, shall provide the following material "was changed to:" the test unit made in the preceding paragraph apply, shall provide the following material "in accordance with the requirements of the relevant safety assessment guidelines, adding a as a fifth:. "GMOs, except as required to submit samples, control samples and test methods, but in accordance with the provisions of this Article 22 has been submitted"

eight to Article 25 revised as follows: "the introduction of GMOs from outside the People's Republic of China, People's Republic of China or to export agricultural genetically modified organisms, shall" provide the appropriate safety assessment of genetically modified organisms imported material provisions of the safety management approach ", and in the application security certificate when requested by GMOs samples, control samples and test methods "

IX, Article 26 will be amended as follows:." apply for genetically modified organisms safety evaluation shall be in accordance with the Ministry of Finance, the national development and reform Commission . the relevant provisions of the pay evaluation fees and inspection fees "

ten, the Article 34 is amended as:" agricultural genetically modified organisms in the testing, production units, shall be subject to the supervision and inspection administrative department of agriculture and before 31 March each year, submit to the testing, production and the provincial people's government at the county level administrative department of agriculture last year testing, production summary report. "

XI, Appendix content mutatis mutandis .

Revised "genetically modified organisms safety evaluation management approach" be announced.

This decision shall become effective October 1, 2016. Ministry of Agriculture
2016





date
genetically modified organisms safety evaluation of management measures



( January 5, 2002 the Ministry of agriculture order No. 8 of July 1, 2004 order of the Ministry of agriculture Amendment No. 38 July 25, 2016 the Ministry of agriculture order No. 7 Amendment)

General Provisions | ||
order to strengthen the management of genetically modified organisms safety evaluation, protection of human, animal and plant health, microbiological safety, protecting the environment, according to "genetically modified organisms safety regulations" (referred to as the "regulations"), development of this approach .

Study in the territory of People's Republic of China engaged in agricultural GMOs second, testing, production, processing, management and import and export activities, in accordance with the "Regulations" require safety assessment shall comply with these measures.

Article III applies to the "regulations" of genetically modified organisms, namely the use of genetic engineering technology to change the genome, and is used for agricultural production or processing of agricultural products of plants, animals, microorganisms and their products, including :


(A) transgenic animals and plants (including seeds, breeding livestock and poultry, aquatic fry) and micro-organisms;

(b) of genetically modified plants and animals, microbial products;

(c) genetically modified directly processed agricultural products;

(iv) contains genetically modified animals and plants, seeds, microorganisms or their products ingredients, breeding livestock and poultry, aquatic fry, pesticides, veterinary drugs, fertilizers and additives and other products.

Article IV of this approach is to evaluate the potential risk or dangerous GMOs on human, animal and plant, microbial ecology and the environment. Safety Assessment in accordance with plants, animals, microorganisms three categories, science-based, case by case review of the principle of phased implementation of hierarchical management.

Article establishment of a national agricultural genetically modified organisms safety committee in accordance with Article IX of the "Regulations", responsible for the safety evaluation of agricultural genetically modified organisms. National Committee is composed of genetically modified organisms safety aspects of genetically modified organisms in research, production, processing, inspection and quarantine, sanitation and environmental protection experts, elected for a term of five years.

Established by the Ministry of Agriculture genetically modified organisms safety management office, responsible for the management of genetically modified organisms safety evaluation.

Article agricultural genetically modified organisms in research and testing organization is primarily responsible for the safety management of agricultural genetically modified organisms, genetically modified organisms safety team should be formed by the unit responsible for the legal representative of the unit in charge of agricultural genetically modified safety management and safety evaluation of biological declaration of the review.

Engaged in agricultural genetically modified organisms research and testing units, test procedures should be developed genetically modified organisms, GMOs trials strengthen traceability management.

Article Ministry of Agriculture needs genetically modified organisms safety evaluation work, entrusted with testing facilities and capabilities of the technical inspection body of agricultural GMOs detection, provide the basis for the safety assessment and management.

Article VIII of genetically modified seeds, breeding livestock and poultry, aquatic plant, the use of genetically modified organisms, or produced seeds containing GMOs ingredients, breeding livestock and poultry, aquatic plant, pesticides, veterinary drugs, fertilizers and additives, etc. before for validation in accordance with relevant laws and administrative regulations, registration or evaluation, approval, shall obtain genetically modified organisms safety certificate in accordance with the provisions hereof.

Chapter II level of safety and security evaluation
IX genetically modified organisms safety evaluation of different levels of management.

According to humans, animals and plants, microorganisms and ecological environment of the degree of danger, the genetically modified organisms into the following four levels:

Safety class I: not dangerous;

security level ⅱ: having a low hazard;

safety class ⅲ: having a moderate risk;

security level ⅳ: highly dangerous.

Article X of genetically modified organisms safety assessment and safety level is determined by the following steps:

(a) to determine the level of security of the recipient organism;

(b) identify genes operating level on biosafety receptor type;

(iii) determine the level of safety of genetically modified organisms;

(iv) determine the effects of the production, processing activities on the safety of genetically modified organisms ;

(e) to determine the level of safety of genetically modified products.

Article XI receptor biosafety level determined

recipient organisms are divided into four security levels:

(a) one of the following conditions receptors biological shall be determined as safety class I:

1. adverse effects on human health and the environment have not occurred;

2. the possibility of harmful organisms evolved into very small;
| || 3. short-term survival for a particular biological receptor research, the possibility of survival after the end of the experiment in the natural environment is minimal.

(Ii) to human health and the environment may produce low risk, but by taking security measures to control the risk of completely avoidable recipient organism, shall be determined as safety class Ⅱ.

(Iii) human health and the environment may have moderate risk, but by adopting safety control measures, basically to avoid the risk of the recipient organism, shall be determined as safety class Ⅲ.

(Iv) human health and the environment may produce highly dangerous, and there is no outside containment facilities appropriate security control measures to avoid the risk of the recipient organism occurs, it should be determined as safety class Ⅳ. Including:

1 high frequency of potentially harmful organism exchange genetic material with other organisms occurs;

2 no effective technology to prevent their escape itself or its products, the spread of harmful organisms; |.. ||
3. there is no effective technology to ensure their escape after, before the adverse effects on human health and the environment, to capture or destroy the pests.

Article XII receptor gene manipulation biosafety level determined

affect the type of genetic manipulation of biological safety level of the receptor is divided into three types, namely: to increase the recipient organism security; does not affect the safety of the recipient organism; reduce the security of the recipient organism.

Increase receptor type 1 gene manipulation biosafety

comprising: removing a (s) known to have dangerous or inhibiting a gene (s) known to have dangerous gene gene expression operation.

Type 2 receptor does not affect the biological safety of gene manipulation

include:

.
1 receptor alter biological phenotype or genotype on human health and the environment will not be affected gene manipulation;.

2 receptor alter biological phenotype or genotype on human health and do not adversely affect the ecological environment of genetic manipulation.

Reduce receptor type 3 bio-safety genetic manipulation

include:.

1 receptor alter biological phenotype or genotype, and on human health or adversely affect the ecological environment of genetic manipulation;

2 receptor alter biological phenotype or genotype, but can not determine human health or ecological effects on the genetic manipulation.

Article XIII genetically modified organisms safety levels determined

influence the type and extent of its influence security level determines the security level of genetically modified organisms according to the security level of the recipient organism and gene manipulation .

(A) class I receptor biosafety of GMOs
1. Safety class I receptor biology, through genetic manipulation Type 1 or Type 2 obtained GMOs, safety Ratings still I.

2. Safety class Ⅰ receptor biological, genetic manipulation by type 3 obtained GMOs, if less secure small and do not need to take any safety control measures, the security level still I; if there is a certain degree of security reduced, but by appropriate security controls to completely avoid the potential hazard, safety class ⅱ; if security is severely degraded, but can be controlled through stringent security measures to avoid potential hazard, its security level ⅲ; if security is severely degraded, and the risk can not be completely avoided by safety control measures, its security level IV.

(Ii) receptor biosafety level of the genetically modified organisms Ⅱ
1. Safety class Ⅱ receptor biological, genetic manipulation by type 1 and obtained by GMOs, if security is increased on human health and the environment are no longer adversely affect, the security level is I; if security has also increased, but to human health and the environment is still low risk, the security level is still ⅱ.

2. Safety class Ⅱ receptor biological, genetic manipulation by type 2 obtained by genetically modified organisms, their safety level remains Ⅱ.

3. Safety class Ⅱ receptor biological, genetic manipulation by type 3 obtained GMOs, according to the degree of security to reduce the different, the security level for Ⅱ, Ⅲ or IV, grading standards receptor grading standards of the same organism.

(C) receptor biosafety level of the genetically modified organisms Ⅲ
1. Safety class Ⅲ receptor organism, genetically modified organisms through genetic manipulation type 1 and obtained according to the increased security to varying degrees, the security level for ⅰ, ⅱ or grading standards ⅲ, grading standards and the same biological receptor.

2. Safety class Ⅲ bio-receptors by genetic manipulation type 2 obtained by GMOs, the security level is still Ⅲ.

3. Safety class Ⅲ bio-receptor through operation type 3 gene was genetically modified organisms, according to the degree of security to reduce the different security levels which may be Ⅲ or IV, with the receptor grading standards grading standards of the same organism.

(Iv) receptor biosafety level of the genetically modified organisms Ⅳ
1. Safety class Ⅳ of the recipient organism, genetically modified organisms through genetic manipulation of type 1 and obtained according to the increased security to varying degrees, the security level can I, ⅱ, ⅲ or IV, grading standards grading standards of the same biological receptor.

2. Safety class IV receptor biology, through genetic manipulation type 2 or type 3 obtained by GMOs, the security level is still IV.

Article XIV agricultural genetically modified products

security levels determine the type and extent of its influence affect the security level is determined based on genetically modified agricultural GMOs safety level and the production, processing activities level of safety of the product. Influence

(a) agricultural genetically modified products, and processing activities on the safety of genetically modified levels divided into three types:

Type 1 increase safety of genetically modified organisms;
|| | type 2 does not affect the safety of genetically modified organisms; 3 types

reduce safety of genetically modified organisms.

(B) the safety of genetically modified GM products class I

1. GMO safety class I GMOs, the Type 1 or Type 2 production and processing activities and the formation of , the security level is still I.

2. Safety class I GMOs, GMO by Type 3 production, processing activity and the formation, according to the degree of security to reduce the different security levels which may be I, Ⅱ, Ⅲ or Ⅳ , grading standards grading standards of the same biological receptor.

(C) the safety of genetically modified genetically modified
grade Ⅱ in
1. GMO safety class Ⅱ of genetically modified organisms, the production, processing activities and the formation of type 1, if the security resistance to human health and the environment are no longer adversely affect its security level I; if there are increased security though, but to human health or ecological risk is still low, it is still safe level ⅱ.

2. GMO safety class Ⅱ of genetically modified organisms, the type 2 production and processing activities and the formation of its security level remains Ⅱ.


3. Security Level Ⅱ of GMOs, genetically modified by Type 3 production, processing activity and the formation, according to the degree of security to reduce the different, the security level for Ⅱ, Ⅲ or Ⅳ, and by the grading standards grading standards of the same organisms.

(Iv) GMO Safety class Ⅲ GM products

1. GMO safety class Ⅲ GMOs through the production, processing activities and the formation of type 1, according to the security different degree increased, the security level for ⅰ, ⅱ or grading standards ⅲ, grading standards and the same biological receptor.

2. GMO safety class Ⅲ GMOs, the Type 2 production and processing activities and the formation of its security level remains Ⅲ.

3. Safety class Ⅲ GMOs, the 3 types of production, processing activities and the formation of genetically modified, according to the degree of security to reduce the different security levels which may be Ⅲ or IV, and by the grading standards grading standards of the same organisms.

(V) GMO Safety class Ⅳ of genetically modified

1. Safety class Ⅳ of genetically modified organisms, the production and processing activities Type 1 and genetically modified products obtained, in accordance with Security different degree increased, the security level can I, ⅱ, ⅲ or IV, grading standards grading standards of the same biological receptor.

2. Safety class IV of GMOs, the Type 2 or Type 3 production and processing activities obtained genetically modified products, their safety level remains IV.


Chapter III Examination and Approval of Article XV in the territory of People's Republic of China engaged in genetically modified organisms safety level units Ⅲ and Ⅳ research and test all security levels and the production and import and processing units and individuals, should be based on the categories of GMOs and security levels, phased reporting to genetically modified organisms safety management office or submit an application.

Article XVI Ministry of Agriculture shall accept genetically modified organisms safety evaluation of the application. Application is accepted, it should be handed over to the National Security Committee of agricultural GMOs safety evaluation. National Agricultural Transgenic Biosafety Committee in its two genetically modified organisms safety review at least annually. To approval in accordance with the "People's Republic of China Administrative Licensing Law" and "Regulations" of the Ministry of Agriculture, after receiving the results of the safety evaluation.

Article XVII engaged in agricultural GMOs trials and imported units as well as units and individuals engaged in the production and processing of agricultural genetically modified organisms, before submitting an application to the safety evaluation report, or genetically modified organisms safety management office shall complete the following Out:

(a) report or the applicant or the applicant and reports are engaged in GMO safety evaluation work, and fill out the report or the declaration;

(2) to organize The unit GMOs security team for a technical review of the application materials;

(c) provide relevant technical information.

Article XVIII in the People's Republic of China engaged in experimental research and testing of agricultural GMOs shall meet the following conditions:

(a) in the territory of People's Republic of China have a special agency; || |
(b) engaged in the research and testing of agricultural GMOs experimental full-time technical staff;

(3) It has equipment and facilities and experimental studies and experiments to adapt;
|| | (d) the establishment of genetically modified organisms safety management team.

Article XIX report agricultural genetically modified experimental study of biological and intermediate tests and for environmental release, unit production tests and safety certificates shall be in accordance with the various stages of the safety evaluation of agricultural genetically modified plants, animals and micro-organisms developed by the Ministry of Agriculture report or reporting requirements, safety assessment of standards and technical specifications, for reports or to apply (see Appendix I, ⅱ, ⅲ, ⅳ).

Diershitiao in security class I biological and experimental study of agricultural genetically modified Ⅱ, approved by the unit genetically modified organisms safety team; Ⅲ and Ⅳ for the experimental study of genetically modified organisms in the level of security, should study begin reporting to genetically modified organisms safety management office before.

Research units to genetically modified organisms safety management office report should provide the following materials:

(a) Experimental study report;

(ii) the safety of agricultural GMOs Ratings and determine security level based;

(iii) the corresponding laboratory safety facilities, security management and preventive measures.

Article 21 after the end of the experimental study of agricultural genetically modified organisms (safety class I, Ⅱ, Ⅲ, Ⅳ) into the middle of the proposed test, the test unit shall report to the genetically modified organisms safety management office.

Test unit to genetically modified organisms safety management office report shall provide the following materials:

(a) intermediate test report;

(b) experimental research summary report;

(c) the level of safety of agricultural GMOs and to determine the level of security based;

(d) appropriate security research, management, and security precautions.


Article 22 at the end of GMOs into the environment intermediate trials intended to release, or after the end of the proposed release into the environment of the production test, the test unit shall apply to genetically modified organisms safety management office, by the national genetically modified organisms safety committee qualified safety evaluation by the Ministry of agriculture for approval before the corresponding test based on approval for genetically modified organisms safety requirements. When

test unit made in the preceding paragraph apply, shall provide the following materials in accordance with the requirements of the relevant safety assessment guidelines:

(a) evaluate the safety declaration;

(ii) agriculture security level and determine security level based on genetically modified organisms;

(c) technical inspection body commissioned by the Ministry of agriculture issued the inspection report;

(d) appropriate security research, security management and preventive measures;

(v) test summary report on a pilot phase;

apply for production test, the samples shall be submitted according to the requirements of genetically modified organisms, control samples and test methods.

Article 23 in the genetically modified organisms safety approval for the validity of the test units need to change the location of the test, shall report to the genetically modified organisms safety management office.

Article 24 at the end of the test intends to apply for genetically modified organisms safety certificate, the test unit shall apply to genetically modified organisms safety management office, the State Security Committee of genetically modified organisms safety evaluation by qualified agriculture after approval before issuing genetically modified organisms safety certificate. When

test unit made in the preceding paragraph apply, shall provide the following materials in accordance with the requirements of the relevant safety assessment guidelines:

(a) evaluate the safety declaration;

(ii) agriculture level of safety of genetically modified organisms and to determine the level of security based;

(c) of the Ministry of agriculture commissioned GMOs technology testing organizations test reports issued;

(IV) intermediate testing, environmental release summary reports and test production test phase;

(e) GMOs required to submit samples, control samples and test methods, but in accordance with the provisions of Article 22 except this has been submitted; || |
(f) other relevant materials.

Article 25 genetically modified organisms safety certificate shall specify the name of genetically modified organisms (number), size, scope, duration and responsible person, security controls and so on. Units and individuals and units imported

engaged in the production and processing of agricultural genetically modified organisms should be undertaken in accordance with the requirements of genetically modified organisms safety certificate and fulfill the obligations specified in the security certificate.

Article 26 from outside the People's Republic of China to introduce genetically modified organisms, or export to the People's Republic of China agricultural genetically modified organisms, shall provide appropriate safety assessment in accordance with the provisions of "import agricultural genetically modified organisms safety management approach" materials and samples required to submit when applying for genetically modified organisms safety certificate, control samples and test methods.

Apply Article 27 genetically modified organisms safety evaluation, the evaluation should pay fees and testing fees in accordance with the Ministry of Finance, the relevant provisions of the State Development and Reform Commission. Staff

Article 28 genetically modified organisms safety evaluation and approval authority accepting experts participate in the review shall be notified in keep technical and business secrets, with themselves and their close relatives have an interest should avoid. Chapter



fourth Detection Management Article 29 The Ministry of Agriculture needs genetically modified organisms safety evaluation and its management, entrusted with the ability to detect the conditions and technical testing bodies .

Article 30 The technical inspection body shall meet the following basic requirements:

(a) impartiality and authority with independent institutions and professionals;
|| | (b) includes the detection and appropriate to the task, in line with national standards (or industry standards) of equipment and testing methods;

(c) the strict implementation of detection technical specifications issued by the test data is accurate and reliable; | ||
(d) appropriate security controls. Article 31 The responsibilities and tasks

technology detection mechanism:

(a) to provide technical services for the management and evaluation of genetically modified organisms safety;

(ii) undertake agriculture Ministry commissioned by the applicant or GMOs qualitative and quantitative inspection, verification and review tasks;

(iii) issue a test report, make a scientific judgment;

(iv) detection techniques and methods undertake or participate in job evaluation and revision of standards and technical regulations;

(e) completion of the test, the sample used for safety testing shall be destroyed, can not be retained;

(vi) the principal applicant and keep technical and business secrets.

Chapter V Supervision and Management and Safety Control
Article 32 The Ministry of Agriculture is responsible for the safety of genetically modified organisms, supervision and management in different ecological regions of genetically modified organisms safety monitoring and surveillance work, to establish a national genetically modified organisms safety supervision and monitoring system.

Article 33 Local people's governments above the county level agricultural administrative departments at all levels responsible for genetically modified organisms safety administrative areas under the provisions of Article 39 and Article 40 of the "Regulations" supervision and management.


Article 34 The relevant units and individuals shall, in accordance Article 41 of the "Regulations", with agricultural administrative departments for supervision and inspection work.

Article 35 engaged in agricultural GMOs testing, production units, shall be subject to the supervision and inspection administrative department of agriculture, and in the year prior to March 31, to test, produce local provincial and county level people Government agricultural administrative departments to submit the test the previous year, the production of the final report.

Article 36 engaged in agricultural GMOs testing and production units shall be determined in accordance with the provisions hereof safety control measures and emergency measures to prevent accidents, do safety oversight records for verification.

Safety control measures including physical control, chemical control, biological control, environmental control and size control (see Appendix Ⅳ).

Article 37 Security Level Ⅱ, Ⅲ, Ⅳ GMOs before waste treatment and disposal should take credible measures to be destroyed, inactivated, in order to prevent proliferation and environmental pollution. Found GMO diffusion residue or harm must take immediate and effective measures to control and eliminate, to the local administrative department of agriculture report.

Article 38 GMOs during storage, transfer, transportation and destruction, when inactivated, should take appropriate safety precautions and management, with a particular device or location, to designate a person to manage and record. Article 39 When

find GMOs dangerous to humans, animals, plants and the environment, the Ministry of Agriculture announced that the right to prohibit the production, processing, management and import to recover genetically modified organisms safety certificate by the owner there is a risk related to the destruction of GMOs.



Chapter VI Penalties Article 40 violation of the provisions, in security level Ⅲ, Ⅳ agricultural genetically modified experimental study of biological or agricultural GMOs in the middle of the trial, was the Ministry of Agriculture report, in accordance with Article 43 of the "regulations" provisions.

Violated the provisions of Article 41, without approval in environmental release, production trials, or have been approved but not to take safety precautions in accordance with the provisions of the management or exceed the approved scope and duration to be tested, in accordance with Article 44 of the "regulations" punishment.

Article 42 violation of the provisions at the end of the production test, without obtaining the genetically modified organisms safety certificate of agricultural GMOs without authorization will be put into production and application, in accordance with the "Regulations" forty-fifth stipulate that punishment.

Article 43 counterfeiting, forgery, transfer or sale of genetically modified organisms safety certificate, approval books and other documents of approval, in accordance with the "Regulations" provisions of Article 53 punishment.

Article 44 violation of the provisions issued approval for genetically modified organisms safety, security certificates and other documents of approval, or fails to perform the duty of supervision after issuance, in accordance with Article 55 of the "Regulations" shall be punished.



Chapter VII Supplementary Provisions Article 45 The terms used in this way and have the following meanings:

a, gene function and structure of the control system of biological traits genetic material units, mainly referring to DNA fragments with genetic information.

Second, genetic engineering techniques, including the use of recombinant DNA technology vector system and the use of physical, chemical and biological methods such as recombinant DNA molecule into the organism technology.

III genome, refers to specific biological chromosomal and genetic material outside the sum of all.

Four, DNA, DNA-based English shorthand term storage of genetic information is the genetic material.

Five genetically modified organisms, refers to the use of genetic engineering technology to change the genome, and is used for agricultural production or processing of agricultural products animals and plants, microorganisms and their products.

Six target gene means the recipient cells to modify its genetic composition and expression of genetic effects of gene purposes.

Seven biological receptor means the recombinant DNA molecule is introduced into organisms.

Eight seeds, means crops and trees planting or propagation material, including grains, fruits, roots, stems, shoots, buds and leaves.

IX, experimental studies, refers to genetic manipulation in the laboratory control system and GMO research.

Ten, intermediate test means in the control system or the control of small-scale tests under conditions.

XI release into the environment, means to take appropriate safety measures test conducted in size under natural conditions.

Twelve, production test, means the pre-production and application of large-scale trials.

Thirteen, control system, by means of physical control, chemical control and biological control to establish a closed or semi-closed operating system.

XIV physical control measures to limit refers to the use of physical methods of genetically modified organisms and their products to survive and spread outside the experimental area, such as fencing, to prevent the escape of genetically modified organisms and their products or people from the experimental area or animal experiments carried to the outside area.

XV chemical control measures, means the use of chemical methods to limit GMO product and its survival, proliferation or residues, such as sterilization of biological materials, tools and facilities.


XVI biological control measures, measures to restrict the use of biological means of genetically modified organisms and their products to survive, spread or residual, and restrictions on genetic material from the genetically modified organisms transferred to other organisms, such as setting up an effective quarantine and surveillance zones clear the test area nearby with GMOs hybrid species of flowering to prevent genetically modified organisms or removal of reproductive organs, or the use of flowering time and other measures to prevent the transfer of the gene of interest to the relevant organisms.

Seventeen environmental control measures, means the use of environmental conditions of genetically modified organisms and their products of survival, reproduction, diffusion or residue, such as control of temperature, moisture, light cycle.

XVIII scale control measures, means as much as possible to reduce the number of genetically modified organisms and their products for trial or reduce the area of ​​the test area, to reduce the possibility of genetically modified organisms and their products are widely diffused in consequence unexpected occurs, can more thoroughly to eliminate genetically modified organisms and their products.

Article 46 of this approach by the Ministry of Agriculture is responsible for interpretation.

Article 47 These Measures shall be effective March 20, 2002. July 10, 1996 issued by the Ministry of Agriculture 7 orders "Agricultural Biological Gene Engineering Safety Management Implementation Measures" shall be repealed simultaneously.















|| |
Appendix I


safety assessment of genetically modified plants a transgenic plant safety evaluation safety evaluation
1
background information of the recipient plant 1.1 recipient plant: || |
1.1.1 scientific name, common name and other names;

1.1.2 taxonomic status;

1.1.3 receptor test plant varieties (or lines) name; || |
1.1.4 is wild or cultivated species;

1.1.5 origin and the introduction of time;

1.1.6 purposes;

1.1.7 in domestic applications;

1.1.8 on human health and the environment whether adverse effects occurred;

1.1.9 Historically, the recipient plant evolved into harmful plants (such as miscellaneous the possibility of grass, etc.);

1.1.10 is there a long record of safe use. Biological characteristics of the recipient plant

1.2:

1.2.1 is an annual or perennial;

1.2.2 on human and other organisms is toxic, such as toxic, should explain the nature of the site and its toxic toxicity exist;

1.2.3 Are there allergens, if any, should indicate the presence of allergens and allergenic properties of the site;

1.2 .4 reproduction is sexual reproduction or asexual reproduction, such as sexual reproduction, is self-pollinated or cross-pollinated or normally cross pollination; or insect pollination is wind pollinated;

1.2.5 under natural conditions the same or closely related species of outcrossing rate;

1.2.6 fertility (fertility or infertility, fertility level, if infertility should explain what that type of infertility );

1.2.7 growth period;

1.2.8 viability of reproduction in nature, including sexual wintering, summering resistance and stress resistance. Ecological Environment

1.3 recipient plant:

1.3.1 domestic geographic distribution and natural habitats; ecological environment

1.3.2 required for growth and development, including natural conditions and cultivation conditions of the possibility of changing the geographical distribution area and scope of its impact;

1.3.3 whether the ecological environment in part;

1.3.4 ecosystem ecological relationships in other plants, including changes in the ecological environment impact of this (these) relations and will therefore increase the arising out of or adverse effects on human health and ecological environment;

1.3.5 and ecology other biological systems (animals and microorganisms) of ecological relationships, including the impact of this change on the ecological environment (s) relations and will therefore generate or increased adverse effects on human health or the environment.

1.3.6 degree of risk and its potential impact on the ecological environment;

1.3.7 When it comes to non-domestic species of plants are usually planted, shall describe the natural habitat of the plant and its related natural predators, parasites and symbionts competitor information.

1.4 receptor genetic variation of plants:

1.4.1 Genetic stability;

1.4.2 Are there genetic variation occurs to human health or ecological environment adversely the impact data;

1.4.3 under natural conditions and the possibility of other plant species genetic material exchanged;

1.4.4 under natural conditions and other organisms (such as microorganisms) the possibility of genetic material exchanged. The possibility

1.5 recipient plant monitoring methods and monitoring.

Additional information 1.6 recipient plant.

1.7 Based on the above evaluation, Hierarchical Secure recipient plant with reference to Article XI of this approach to the relevant standards. Safety Assessment

2 gene manipulation
2.1 transgenic plants introduced or modified traits and characteristics described. The following information

2.2 actually inserted or deleted sequence:

2.2.1 insert size and structure of the sequence analysis method to determine its characteristics;

2.2.2 Remove the region size and function; amino acid sequence

2.2.3 target gene nucleotide sequence and the deduced;


2.2.4 insert positioning sequences in plant cells (whether integrated into the chromosome, chloroplasts, mitochondria, or in a non-integrated form) and its determination method;

2.2.5 insert copy number sequence .

2.3 of the target gene and vector maps, the name of the carrier, origin, structure, characteristics and safety, including whether there are pathogenic carrier and the possible evolution of pathogenicity.

2.4 vector fragment was inserted into the region's Information:

2.4.1 Start the name promoter and terminator of size, function and donor organism;

2.4. name size 2 marker gene and reporter gene function and donor organism;

2.4.3 other expression control sequence name their sources (such as artificial or donor organism name).

2.5 transgenic methods.

2.6 Expression of the inserted sequence data:

2.6.1 insert sequence organ and tissue expression, such as roots, stems, leaves, flowers, fruits and seeds;

2.6.2 the insertion sequence and expression analysis methods;

2.6.3 insert stability sequence expression.

2.7 Based on the above evaluation, with reference to Article 12 of the related standards genetic manipulation security type.

3 transfer safety evaluation
modified plants 3.1 transfer genetic stability of the transgenic plants.

3.2 difference receptor transgenic plants or parent plants in terms of environmental safety:

3.2.1 mode of reproduction and fertility;

3.2.2 and dissemination ability to communicate;

3.2.3 dormancy;

3.2.4 adaptability;

3.2.5 survive competitiveness;

3.2.6 transgenic the possibility of transfer of plant genetic material occurs to other plants, animals and microorganisms;

3.2.7 into the possibility of weeds;

3.2.8 pest resistant transgenic plants on target and biological effects of non-target species, including the impact on the environment beneficial and harmful organisms; other beneficial or detrimental effects

3.2.9 on the ecological environment.

3.3 of transgenic plants with the receptor or parental plants in terms of differences in human health effects:

3.3.1 Toxicity;

3.3.2 allergic;

3.3.3 anti-nutritional factors;

3.3.4 nutrients;

3.3.5 antibiotic resistance;

3.3.6 on human and food safety the other effects.

3.4 Based on the above evaluation, with reference to Article 13 of the related standards transgenic plant safety level.

4 safety evaluation of genetically modified plant products
4.1 production, processing activities impact on the safety of transgenic plants.

4.2 transfer genetic instability plant products.

4.3 transgenic plant transgenic plant product differentiation in terms of environmental safety and turn.

4.4 transgenic plant transgenic plant products and differences in health effects on humans.

4.5 Referring to Article 14 of the related standards transgenic plant product safety rating.

Second, the transgenic plant test program

1
test site topography and meteorological information 1.1 provides test sites, test sites on the environment to make a general description of specific locations marked tests.

1.2 testing ground is a natural ecological type or types of agro-ecological surroundings. If the natural ecological type, then the distance from the agro-ecological type region; if the agro-ecological types, include the name of the common pest and crop infestation, prevalence.

1.3 include the name of the name-related cultivated species and wild species around the testing ground, and common weeds and damage their brief case.

1.4 include major animal species around the testing ground, whether there are rare and endangered and protected species. Favorable or unfavorable factors

1.5 ecological environment of the test location transgenic plant survival, reproduction, diffusion and dissemination, in particular the possibility of other organisms in the environment of target gene obtained from transgenic plants.

2 experimental design

2.1 starting and ending time field trials.

Area of ​​22,000 test sites (not including the area of ​​the isolating material).

2.3 data transfer cultivation of genetically modified plants:

2.3.1 transgenic plant species, strain, material name (number);

2.3.2 transgenic plant varieties, or strains material in each test site acreage;

2.3.3 transfer the amount of modified plants;

2.3.4 transgenic plants on how to pack and ship to test ground;

2.3. 5 transgenic plant is a mechanical planting or planted.

2.4 transgenic plant growth period in the case of the proposed use of pesticides.

2.5 transgenic plants and their products harvested Information:

2.5.1 transgenic plant is solid;

2.5.2 are mechanical or manual harvesting harvest, how to avoid loss; how

2.5.3 post-harvest preservation of plants and their transgenic products.

3 safety control measures
3.1 isolation measures:

3.1.1 isolating distance;

types and configurations 3.1.2 quarantine of plants;
| || 3.1.3 in what way to prevent pollen spread beyond the testing ground;


3.1.4 Quasi other isolation measures adopted. Measures transgenic plants and their genes to prevent the spread of

3.2. Emergency measures accidents occur

3.3 during the test. The residual portion

3.4 harvestable parts other than how to deal with.

3.5 harvest testing ground monitoring:

3.5.1 to test the person in charge of monitoring and Information;

3.5.2 to test whether the left boundary markers;

3.5.3 after the test control measures and life. Report

Third, the various stages of the transgenic plants reporting requirements

1 intermediate test requirements

1.1 Project Title: should contain the target gene name, the name of transgenic plants, test the province ( municipalities and autonomous regions) the name and the name of the pilot phase of four parts, such as the transfer of Bt transgenic cotton in the middle of Hebei Province and Beijing test.

1.2 test gene transfer quantity of plant material: a report on the book transformed body should be made of the same recipient plant (varieties or lines no more than 5), the same target gene, the same gene manipulation obtained , and each transformed body should have a clear name or number.

1.3 Experiment site and scale: the test site should be legal entities, each test point area of ​​not more than 4 acres (perennials, as the case may be). Test test site should be clear where the province (autonomous regions), county (city), township and village and coordinates.

1.4 test period: usually one to two years (perennials, as the case may be).

1.5 intermediate test report shall provide the following general information related accessories:

1.5.1 nucleotide sequence of the target gene and its deduced amino acid sequence;

1.5.2 the target gene and vector maps; gene and plant genomic integration and expression of molecules

1.5.3 object detection or identification results (PCR detection, Southern blot analysis or Northern analysis);
|| | 1.5.4 detection of gene transfer traits and their products, identification techniques; position

1.5.5 test site topographic map of isolation and cultivation of FIG;

1.5.6 intermediate test procedures ( including storage of transgenic plants, removal, destruction, harvesting, post-harvest monitoring, action and management of accidental release of test points);

1.5.7 experimental design (including the main indicators of the safety evaluation and research methods, such as the transfer of genetic stability, agronomic traits, ability to adapt to the environment of genetically modified plants, the survival of competitiveness, the effectiveness of foreign genes in plant tissues and organs of expression and functional traits, etc.).

2 environmental release reporting requirements

2.1 Project Name: should include the name of the target gene, transgenic plant name test where the provinces (municipalities and autonomous regions) the name and the name of the pilot phase of four parts, such as of Bt cotton NY12 insecticidal gene NM36 and release in the environment of Hebei Province and Beijing.

2.2 test gene transfer quantity of plant material: a return in the book by the same transformant should be the recipient plant species or strains, the same target gene, the same gene manipulation method to obtain each transformant It should have a clear name or number, and the corresponding intermediate pilot phase.

2.3 Experiment site and scale: each test point area no more than 30 acres (generally greater than 4 acres, perennials, as the case may be). Test test site should be clear where the province (autonomous regions), county (city), township and village and coordinates.

2.4 test period: a declaration of environmental release period is generally one to two years (perennials, as the case may be).

2.5 application release into the environment in general shall provide the following information related accessories:

2.5.1 nucleotide sequence of the target gene and its deduced amino acid sequence;

2.5.2 (PCR detection Southern blot analysis Northern or Western analysis of the target gene product expression detection or identification of the gene results

plant genomic integration and expression of molecules 2.5.3 purpose,,,; the target gene and vector maps result);

2.5.4 detection of gene transfer traits and their products, identification techniques;

2.5.5 experimental studies and pilot test summary report;

2.5.6 test location topographic map of locations;

2.5.7 release into the environment of procedures (including storage of transgenic plants, removal, destruction, harvesting, post-harvest monitoring, action and management of accidental release of test points);

2.5.8 experimental design (including major indicators and research methods of safety assessment, such as the transfer of genetic stability, agronomic traits, ability to adapt to the environment of genetically modified plants, the survival of competitive exogenous gene in the plant organizations stability of expression and organ functional traits, and can be mated and genetic drift associated species, effects on non-target organisms, etc.). Declare

3 production test requirements

3.1 Project Name: should include the name of the target gene, transgenic plant name, (municipalities and autonomous regions) the name and the name of the pilot phase of four test portions of the province, such as the transfer of Bt transgenic cotton NY12 production test in Hebei Province and Beijing.

3.2 test gene transfer quantity of plant material: a declaration of no more than five lines in the book, these lines should be the same transformant, its name should be the pre-trial phase corresponds to the name or number.


3.3 Experiment site and scale: environmental release should be approved over the provinces (municipalities and autonomous regions) carried out each test point area of ​​more than 30 acres (perennials, as the case may be). Test test site should be clear where the province (autonomous regions), county (city), township and village and coordinates.

3.4 test period: a declaration of productive testing period is usually one to two years (perennials, as the case may be).

3.5 application for production test shall provide the following general information related accessories:

3.5.1 nucleotide sequence of the target gene and its deduced amino acid sequence;

3.5. plant genes and genomic integration and expression of molecules

3.5.3 object detection or identification results (PCR detection, Southern blot analysis, Northern or Western analysis showed that the target gene product; 2 of the target gene and vector maps expression of results);

3.5.4 transgenic trait and product detection and identification techniques; photocopy of approval for environmental release phase

3.5.5;

3.5. 6 each test phase of the trial results and safety evaluation test summary report; location topographic map

3.5.7 test sites; rules

3.5.8 production trials (including transgenic plants storage, removal, destruction, harvesting, post-harvest monitoring, action and management of accidental release of test points);

3.5.9 experimental design (including safety evaluation of key indicators and research methods, such as transfer of genetic stability of the transgenic plants, survival competitiveness, genetic drift is detected, effects on non-target organisms, food safety, such as nutrition analysis, anti-nutritional factors, whether or not containing toxic substances, whether or not containing allergens, label security genes necessary acute, sub-acute animal test data, etc.);

3.5.10 transgenic plant as a parent and conventional varieties of the plant (or other transgenic plant varieties or lines) obtained hybrids containing genetically modified ingredients should be provided information on its name and its parent breeding process and provide proof of their gene-test data and information. Declare

4 security certificate requirements

4.1 Project Name: should include the name of the target gene, transgenic plant name, security certificate application where appropriate ecological zones and other parts, such as insect-resistant gene transfer cry1Ac cotton XY12 security certificate applications in the Yellow River Basin.

4.2 a declaration can only apply for a strain of transgenic plants (or species), its name should be the pre-trial phase corresponds to the name or number. Lines should be consistent with the name "Agricultural Plant Variety naming convention."

4.3 a transgenic plant lines (or varieties) should have been approved production test suitable ecological zones to apply for a safety certificate.

4.4 application security certificates using a general term not exceeding five years.

4.5 application security certificate shall provide the following general information Accessories:

4.5.1 nucleotide sequence of the target gene and its deduced amino acid sequence;

4.5.2 Objective gene map and vector construction; gene and plant genomic integration and expression of molecules

4.5.3 object detection or identification results (PCR detection, Southern blot analysis, Northern or Western analysis, the results of the expression of the target gene product );

4.5.4 transgenic trait and product detection and identification techniques;

copy 4.5.5 each test stage of the approval of the book;

4.5.6 each test safety evaluation test summary report stage;

4.5.7 ecological environment safety evaluation report transgenic plants;

4.5.8 evaluation report on food safety, including: a ) required animal toxicology test reports; B) food allergy evaluation test report; C) compared with non-transgenic plants, their nutrients and anti-nutritional factors analysis reports;

4.5.9 such transgenic plants application of domestic and foreign production before;

4.5.10 field monitoring program, including monitoring technology, resistance management measures to long-term environmental effects research methods;

needed to review other 4.5.11 Relevant information.

4.6 application for the certificate of safety of genetically modified transgenic plants shall be subject to the approval of the Ministry of Agriculture for the production test, and can apply a security certificate at the end of the test.

4.7 transgenic plants after obtaining the genetically modified organisms safety certificate before as germplasm resources. Made with genetically modified organisms safety certificate transgenic plant as a parent hybrids and conventional hybrid varieties obtained, shall declare the beginning of the production from the safety evaluation of the pilot phase.

Appendix II


gene transfer animal safety evaluation of a transgenic animal safety evaluation
1 recipient animal safety evaluation
Background 1.1 recipient animal:

1.1.1 scientific name, common name and other names;

1.1.2 taxonomic status;

1.1.3 receptor test animal species name;
| || 1.1.4 is wild or domesticated species;

1.1.5 origin and the introduction of time;

1.1.6 purposes;

1.1.7 in the country application;

1.1.8 on human health and the environment whether adverse effects occurred;

1.1.9 Historically, the recipient animals evolved into the possibility of harmful animals; | ||
1.1.10 is there a long record of safe use.


1.2 recipient animal biological characteristics:

1.2.1 Development Stages of biological characteristics and life cycle;

1.2.2 Diet;
| || 1.2.3 reproduction and reproductive capacity;

1.2.4 migration and abilities;

1.2.5 colonization ability. Including the recipient animal's competitiveness and its impact sexual encroachment colonization ability in the environment, the impact of population size on reproduction and migration;

1.2.6 aggressive to humans and animals, toxicity;

1.2.7 the possibility of the ecological impact on the environment. Situation and its potential impact

1.3 recipient animal pathogens:

1.3.1 whether a particular pathogen infection is easy;

1.3.2 Natural Environment types and distribution of pathogens, the occurrence and spread of animal diseases receptor, it is important to reduce the economic performance and on human health and the environment and the adverse impact;

1.3.3 other pathogens on the environment influences. Ecological Environment

1.4 recipient animal:

1.4.1 domestic geographic distribution and natural habitats, this natural distribution is due to changes in certain conditions change;
ecological environment
1.4.2 growth required;

1.4.3 whether the ecological environment in part, on the grass, water environment;

1.4.4 whether specific ecology, such as adaptability in the environment;

1.4.5 habits, can survive independently, or co symbiosis;

1.4.6 survive in the environment abiotic factors affect the ability of the mechanism and conditions, predators, forage (feed or food) or other biological factors and climate, soil, water, etc. to their survival;

1.4.7 other animals and ecosystems the ecological relationships, this (these) affect the relationship and whether it will therefore generate or increase adverse effects on human health and ecological environment, including changes in the ecological environment;

1.4.8 other ecosystems organisms (plants and microorganisms) of ecological relationships, including changes in the ecological environment impact of this (these) relations and will therefore increase the arising out of or adverse effects on human health or the environment.

1.4.9 degree of risk and its potential impact on the ecological environment; when

1.4.10 relates generally to non-domestic animal species farmed, shall describe in detail the animal's natural habitat and related their natural predators, parasites and symbionts competitor information.

1.5 receptor genetic variation of animals:

1.5.1 genetic stability, including the possibility of exogenous DNA-binding and, if there are exchange factor, whether active antiviral substances to their normal chromosomes interaction, whether due to mutations observed abnormal genotype and phenotype caused;

1.5.2 Are there genetic variation occurs an adverse effect on human health or ecological data;
|| | 1.5.3 under natural conditions the possibility to exchange genetic material with other animal species carried;

1.5.4 microorganisms under natural conditions (particularly pathogens) the possibility of genetic material exchanged. Monitoring

1.6 recipient animal and the possibility of monitoring. Additional information

1.7 recipient animal.

1.8 Based on the above evaluation, dividing the recipient animal safety level standards with reference to Article XI of this approach. Safety Assessment

2 gene manipulation
2.1 transgenic animals introduced or modified traits and characteristics described. The following information

2.2 actually inserted or deleted sequence:

2.2.1 insert size and structure of the sequence analysis method to determine its characteristics;

2.2.2 Remove the region size and function;

2.2.3 nucleotide sequence and the deduced amino acid sequence of the target gene;

2.2.4 targeting sequence inserted in animal cells (whether integrated into the chromosome, mitochondria, or non-integrated form) and its determination method;

2.2.5 insert copy number sequences.

2.3 of the target gene and vector maps, the carrier's name and source of support if there are pathogenic and may evolve into whether there are pathogenic. The case of viral vectors, it should explain its role and whether the recipient animals can be replicated.

2.4 vector fragment was inserted into the region's Information:

2.4.1 Start the name promoter and terminator of size, function and donor organism;

2.4. name size 2 marker gene and reporter gene function and donor organism;

2.4.3 other expression control sequence name their sources (such as artificial or donor organism name).

2.5 transgenic methods.

2.6 Expression of the inserted sequence data:

2.6.1 insert sequence information and expression analysis methods, such as Southern blot hybridization diagram, PCR-Southern blot maps;
| || 2.6.2 expression of the inserted sequence of organs and tissues, the expression level.

2.7 Based on the above evaluation, with reference to Article 12 of the related standards genetic manipulation security type.

3 transgenic animal safety evaluation
3.1 compared with the recipient animal, the following characteristics of transgenic animals whether to change:

3.1.1 ability to survive in nature;



3.1.3 reproduction, genetic and other biological properties;
3.1.2 economic performance.

3.2 inserted genetic stability sequence.

3.3 gene expression products, concentration of the product and its distribution in edible tissues.

3.4 transfer animal genes into the genetic material of the ability and the potential consequences of other organisms.

3.5 data produced by the genetic manipulation of toxic or harmful effects on human health and the environment.

3.6 unpredictable whether human health or ecological hazards exist.

3.7 transgenic animal transgenic trait detection and identification technologies.

3.8 in accordance with the relevant provisions of the evaluation and food hygiene, with reference to Article 13 of the related standards transgenic animal level of security.

4 safety evaluation of genetically modified animal products
4.1 transgenic animal product stability. Impact on the safety of transgenic animals

4.2 production and processing activities.

4.3 transgenic animal product differentiation in terms of environmental safety of transgenic animals.

4.4 transgenic animal products in terms of differences in human health effects with the transgenic animals.

4.5 Referring to Article 14 of the related standards transgenic animal products safety rating.

Second, the transgenic animal testing program

1
1.1 test site and test site meteorological data.

Ecotype 1.2 test sites.

1.3 of animal species around the test site. Ecological Environment

1.4 test sites of the transgenic animal survival, reproduction, diffusion and dissemination of favorable or unfavorable factors. In particular, the possibility of other organisms in the environment to obtain the desired gene from transgenic animals.

2 experimental design

2.1 Test starting and ending time.

2.2 transgenic animal species, strain name (ID).

2.3 transgenic animal species, strain in the sizes of the test sites.

2.4 transgenic animals and their production, packaging and storage methods products.

2.5 Gene transfer amount of animals and their products, the remainder of the treatment.

2.6 transgenic animal breeding, slaughtering, processing and storage mode.

3 safety control measures
3.1 isolation mode, along with the test design. Residue or remainder of the processing method

3.2 transgenic animals slaughtered and processed.

3.3 measures to prevent the spread of transgenic animals. Emergency measures accidents occur

3.4 test implementation.

3.5 test and contact person responsible for monitoring the way the whole process.

After 3.6 years of testing and monitoring measures. Report

Third, the various stages of transgenic animals reporting requirements

1 intermediate test requirements

1.1 Project Name: should include the name of the target gene transgenic animal names, test the province ( city, district) name, and the name of the pilot phase of four parts, such as growth-promoting gene transfer GH carp pilot study in Hunan Province and Shanghai.

1.2 Number of test transgenic animal material: report book transgenic animal lines (material) should be from the same species of the recipient animal, the same target gene, the same gene manipulation obtained, and each strain (material) should have a clear name or number.

1.3 Experiment site and scale: the test site should be legal entities, each test point scale (upper limit) for the large animals (horses, cattle) from 10 to 20; small animals (pigs, sheep, etc.) 20 to 40 (only); poultry (chicken, duck, etc.) 100 to 200 birds (only); fish from 2000 to 5000 and so on. Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

1.4 test period: usually one to two years (the generation interval of more than a few years, as the case may be).

1.5 intermediate test report shall provide the following general information related accessories:

1.5.1 nucleotide sequence of the target gene and the deduced amino acid sequence;

1.5.2 Objective gene and vector diagram;

1.5.3 target gene integrated into the molecular detection or identification of animals and the results of the expression (PCR detection, Southern blot analysis or Northern analysis);

1.5. 4 transgenic trait and product detection and identification techniques;

1.5.6 intermediate test procedures (including transgenic; position

1.5.5 test site topographic map and aquaculture quarantine FIG. storage and transportation of animals, breeding, slaughter, destruction, monitoring after the end of the test, the action and the management of the pilot sites of accidents, etc.);

1.5.7 experimental design (including key indicators of safety assessment and research methods, such as the stability of trait expression in transgenic animals objectives, economic performance, competitive survival, adaptability, effectiveness of exogenous functional genes in animal tissues and organs of expression and functional traits, etc.).

2 environmental release reporting requirements

2.1 Project Name: should include the name of the target gene transgenic animal names, test location (city, district) name, and the name of the pilot phase of four in some provinces, such as GH growth-promoting gene transfer carp A12 and T19 environmental release in Hunan Province.


2.2 Number of test gene transfer animal material: book a return transgenic animals up to more than five lines, these lines should be made of the same recipient animal, the same target gene, the same gene manipulation to get, and each strains should have a name or number, and the corresponding intermediate pilot phase.

2.3 Experiment site and scale: the size of each test point (upper limit) for the large animals (horses, cows) 150; small animals (pigs, sheep, etc.) 500 (only); poultry (chicken, duck etc.) 3000 Yu (only); 10,000 to 50,000 fish and so on. Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

2.4 test period: a declaration of environmental release period is generally one to two years (the generation interval of more than a few years, as the case may be).

2.5 application release into the environment in general shall provide the following information related accessories:

2.5.1 nucleotide sequence of the target gene and its deduced amino acid sequence;

2.5.2 the target gene and vector maps;

2.5.3 integration of the target gene (PCR detection, Southern or Northern hybridization analysis results of the analysis, the results of the expression of the target protein) molecule detection or identification result and expression in animal feed;

2.5.4 transgenic trait detection and identification technology and its products;

2.5.5 intermediate test results and safety evaluation test summary report;

2.5.6 test location terrain and isolated locations schematic;

2.5.7 release into the environment of procedures (including transgenic animals, transportation, breeding, slaughter, destruction, monitoring after the end of the test, the action of the accident and tests point management);

2.5.8 experimental design (including key indicators and methods of safety evaluation, etc., such as transgenic animals stability, economic performance and competitive survival, adaptability, foreign functional stability and effectiveness of the gene in animal tissues and organs of expression and functional traits, genetic drift is detected, effects on non-target organisms, etc.). Declare

3 production test requirements

3.1 Project Name: should include the name of the target gene, transgenic animal name, test name and test where the names of the four stages of some provinces (cities, districts), such as growth-promoting gene transfer GH carp A112 production test in Hunan Province.

3.2 Number of test gene transfer animal material: book a return transgenic animals no more than three lines, these lines should be made of the same recipient animal, the same target gene, the same gene manipulation obtained. Varieties or lines should have a clear name, and with the previous pilot phase corresponds to the name or number.

3.3 Experiment site and scale: environmental release should be approved over the provinces (municipalities and autonomous regions) carried out for each test point scale (upper limit) for the large animals (horses, cows) 1000; small animals (pigs , sheep, etc.) 10000 (only); poultry (chicken, duck, etc.) 20,000 birds (only); 100,000 to 300,000 fish and so on. Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

3.4 test period: the first application of productive testing period is usually one to two years (long generation interval, as the case may be).

3.5 application for production test shall provide the following general information related accessories:

3.5.1 nucleotide sequence of the target gene and its deduced amino acid sequence;

3.5. 2 of the target gene and vector maps;

3.5.3 target gene integrated into the molecular detection or identification of animals and the results of the expression (PCR detection, Southern or Northern hybridization analysis results of the analysis, the results of the expression of the target protein) ;

3.5.4 transgenic trait detection and identification technology and its products;

3.5.5 environmental approval for a copy of the release phase;

3.5.6 each test stage trial results and safety evaluation test summary report; location topographic map

3.5.7 test sites;

3.5.8 Practice for production test (including a transgenic animal transportation, raising, slaughter, destruction, monitoring after the end of the test, the action and the management of the pilot sites of accidents, etc.);

3.5.9 experimental design (including key indicators and safety assessment methods, etc., such as genetically modified stability, economic performance of animals, survival competitiveness, adaptability, stability of exogenous gene function in animal tissues and organs of expression and functional traits, validity, genetic drift, effects on non-target organisms, food safety such as nutrition component analysis, anti-nutritional factors, whether or not containing toxic substances, whether there are allergic reactions, acute, sub-acute animal test data, etc.);

3.5.10 for transgenic animals as parents and get regular crossbreed containing genetically modified ingredients in animal shall provide information on the name of its parent and its selection process and provide proof of their gene-test data and information. Declare

4 security certificate requirements

4.1 Project Name: should include the name of the target gene, several parts of the transgenic animal names, such as a GH transfer security certificate gene carp growth of A112.


4.2 can only apply for a declaration of a transgenic animal breeds or strains, its name should be before each test phase corresponds to the name or number.

4.3 application security certificates using a general term not exceeding five years.

4.4 application security certificate shall provide the following general information related accessories:

4.4.1 nucleotide sequence of the target gene and its deduced amino acid sequence;

4.4.2 the target gene and vector maps;

4.4.3 integration of the target gene (PCR detection, Southern or Northern hybridization analysis results of the analysis, the results of the expression of the target protein) molecule detection or identification result and expression in animal feed;

4.4.4 transgenic trait detection and identification technology and its products;

copy 4.4.5 each test stage of the approval of the book;

4.4.6 each test phase test results and safety evaluation test summary report;

4.4.7 transgenic animal genetic stability, economic performance and competitiveness, ability to adapt to survive such a comprehensive evaluation report;

4.4.8 outside gene expression profile in animal tissues and organs;

4.4.9 on ecological environment comprehensive safety evaluation report of transgenic animals;

4.4.10 food safety Inspection report: a) animals toxicological test report B) food allergy evaluation test report C) compared with non-transgenic animal, its nutritional ingredients and anti-nutritional factors analysis report;

4.4.11 domestic and foreign production of such transgenic animals before application; | ||
4.4.12 the transgenic animals may survive surveillance program areas, including research methods monitoring technology, resistance management measures to long-term environmental effects;

4.4.13 needed to review other related data.

4.5 transgenic animals shall be subject to the approval of the Ministry of Agriculture for the production test, and can apply a security certificate at the end of the test.

4.6 transgenic animals after obtaining the genetically modified organisms safety certificate before as germplasm resources. Contains genetically modified ingredients in animal genetically modified organisms safety certificate has been made in a transgenic animal as a parent with a conventional hybrid varieties obtained, shall declare the beginning of the production from the safety evaluation of the pilot phase. Appendix Ⅲ


safety assessment of genetically modified microorganism according
safety assessment needs of the genetically modified microorganism into a plant genetically modified microorganisms, animals, and other genetically modified micro-organisms genetically modified micro-organisms.

A plant with a safety assessment of genetically modified microorganism
(a) use of plant safety assessment of genetically modified micro-organisms safety evaluation
1
1.1 recipient microorganism recipient microorganism background information: | ||
1.1.1 scientific name, common name and other names;

1.1.2 taxonomic status;

1.1.3 test recipient microorganism strain name;
|| | 1.1.4 is natural or artificial cultivation of wild species of bacteria;

1.1.5 origin and the introduction of time;

1.1.6 purposes;

1.1.7 in domestic applications;

1.1.8 to human health or the environment, whether adverse ecological impact occurred;

1.1.9 Historically, the recipient microorganism may evolve into a pest sex;

1.1.10 is there a long record of safe use. Biological characteristics

1.2 recipient microorganism:

1.2.1 growth period and generation time;

1.2.2 Reproduction and reproductive capacity;
|| | 1.2.3 suitable growth of the nutritional requirements;

1.2.4 host range;

1.2.5 colonization in the environment, survival and spread expansion, ability and its influencing factors ;

1.2.6 pathogenic to humans and animals, whether or produce toxic substances;

1.2.7 on plant pathogenic;

1.2.8 other important biological school characteristics. Ecological Environment

1.3 recipient microorganism:

1.3.1 domestic geographic distribution and natural habitats, its natural distribution is due to changes in certain conditions change;
| || 1.3.2 growth required habitat conditions, including temperature, humidity, pH, light, air, etc;

1.3.3 whether the ecological environment in part, to farmland soil, vegetation, Effect of land, grassland, water environment;

1.3.4 whether specific ecology, such as adaptability in the environment; ecological

1.3.5 and other microbes in the ecosystem relations, including changes in the ecological environment of this (these) affect the relationship and whether it will therefore generate or increase adverse effects on human health and ecological environment;

1.3.6 other organisms and ecosystems ( plants and animals) of ecological relationships, including changes in the ecological environment impact of this (these) relations and will therefore increase the arising out of or adverse effects on human health or the environment.

1.3.7 degree of risk and its potential impact on the ecological environment;

1.3.8 when it comes to non-domestic species of plants are usually planted, shall describe in detail the natural habitat of the plant and related their natural predators, parasites and symbionts competitor information.

1.4 recipient microorganism genetic variation:

1.4.1 Genetic stability;

1.4.2 plasmid situation, stability and the degree of potential risk plasmid; | ||
1.4.3 transposons and transposable elements and their potential health risk level;


1.4.4 Is there information on the occurrence of genetic variation and adverse effects on human health or ecological environment;

1.4.5 under natural conditions and other microorganisms (particularly pathogens) genetic material exchange the possibility;

1.4.6 under natural conditions and the possibility of plant genetic material exchanged;

1.4.7 under natural conditions and the possibility of animal genetic material exchanged. Monitoring

1.5 recipient microorganism and the possibility of monitoring.

Additional information 1.6 recipient microorganism.

1.7 recipient microorganism determine the level of security in accordance with Article XI of this approach relevant standards. Safety Assessment

2 gene manipulation
2.1 with the introduction of genetically modified plants or microorganisms described modified traits and characteristics.

2.2 actually inserted or deleted sequence data:

2.2.1 insert size and structure of the sequence analysis method to determine its characteristics;

2.2.2 Remove the region size and function.

2.2.3 nucleotide sequence and the deduced amino acid sequence of the target gene;

2.2.4 insert copy number sequences.

2.3 carrier's name and the source, vehicle characteristics and safety, can not contain micro-organisms in nature to the transfer of such genes; vector construction map.

2.4 vector fragment was inserted into the region's Information:

2.4.1 Start the name promoter and terminator of size, function and donor organism;

2.4. name size 2 marker gene and reporter gene function and donor organism;

2.4.3 other expression control sequence name their sources (such as artificial or donor organism name).

2.5 genetic manipulation methods.

Stability prospects for survival and expression of the gene of interest 2.6.

2.7 technology for detecting and identifying the gene of interest.

2.8 recombinant DNA molecule structure, replication characteristics and safety.

2.9 to determine the safety of this type of genetic manipulation in accordance with Article 12 of the relevant standard.

3 plants use rotary safety assessment of genetically modified microorganism
3.1 compared with the recipient microorganism, plant genetically modified micro-organisms whether to change the following features:

3.1.1 colonization;

3.1.2 viability;

3.1.3 propagation scalability;

3.1.4 toxicity and pathogenicity;

3.1.5 genetic variation capacity; the possibility

3.1.6 monitored;

ecological relationship 3.1.7 and plants;

3.1.8 ecological relations with other microorganisms;
| || 3.1.9 ecological relationships with other organisms (animals and humans), and the possibility of human exposure and risk of adverse effects arising from the elimination of way;

3.1.10 other important biological characteristic.

3.2 Application of plant types and uses. Compared with the related bio-pesticides, bio-fertilizers, its performance characteristics and relative safety. Range

3.3 test application, there may be scope in the environment, widely used after the potential impact.

3.4 to the target organism beneficial or harmful effects.

3.5 on non-target organisms beneficial or harmful effects.

3.6 Plants genetically modified micro-organisms transgenic trait monitoring methods and detection and identification techniques.

3.7 determine plant genetically modified microorganism according to the security level Article 13 of the relevant standard.

4 plant genetically modified micro-organisms in the product safety assessment of genetically modified microorganism
4.1 product stability. On the safety of genetically modified micro-organisms

4.2 production and processing activities.

4.3 genetically modified micro-organisms difference microbial products in terms of environmental safety and turn.

4.4 of genetically modified micro-organisms and products of genetically modified micro-organisms to differences in terms of human health effects.

4.5 Referring to Article 14 of the related standards plant genetically modified microbial products level of security.

(Ii) plant microbiological testing program transgenic

1
test site location meteorological data 1.1 test sites, topography, a general description of the test site environment, indicating the test sites FIG.

Ecotype 1.2 testing ground around it.

1.3 release animal, plant species around the place. Survival ecological environment

1.4 release place the plant genetically modified micro-organisms, reproduction, diffusion and dissemination of favorable or unfavorable factors, notably the possibility of other organisms in the environment of the target gene obtained from genetically modified organisms.

2 experimental design

starting and ending time of the test 2.1.

2.2 test strain name or number.

2.3 to be carried out and the test area test sites.

2.4 production, packaging, storage and transportation to the testing ground approach.

2.5 use and dose, disposal unused portion.

Cultivation methods 2.6 test plants, field management practices.

3 security controls
3.1 security isolation test sites:

3.1.1 Isolation mode and isolation distance;

3.1.2 prevent transgenic plants measures microbial proliferation; emergency measures accidents occur

3.1.3 during the test; monitoring and leaders and Information

3.1.4 during the test.

After the end of the period
3.2 tests and test, test sampling or harvesting of plants, residual or remaining part of the treatment. After

3.3.2 test;

after the end of the test safety monitoring plan 3.3.1 The test site and its surroundings: After

3.3 Test control measures monitoring years;

3.3.3 monitoring and leaders and contact information. Reports of the stage

(c) plant with GM microorganisms reporting requirements

1 intermediate test requirements

1.1 Project Title: should contain the target gene name, the name of the gene transfer of microorganisms, (municipalities and autonomous regions) the name and the name of the pilot phase of four test portions of the province, such as genetically Bacillus thuringiensis Cry1Ac Jiyin Su cloud pilot study in Guangdong Province.

1.2 Number of gene transfer experiment microbial strains: A report in the book should be made of the same strain of microorganism receptor (recipient strain no more than 5), the same target gene, the same gene manipulation obtained, and each transgenic strain should have a clear name or number.

1.3 Experiment site and scale: the test site should be legal entities, each test point area of ​​not more than 4 acres. Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

1.4 test period: usually one to two years.

1.5 intermediate test report shall provide the following general information related accessories:

1.5.1 amino acid sequence of the target gene nucleotide sequence and the deduced;

1.5.2 Objective gene, the vector map and construct genetically modified micro technology roadmap;

1.5.3 microbiological and toxicological test reports receptor transgenic microorganisms or relevant literature; map

1.5.4 test sites FIG isolation and testing;

1.5.5 intermediate test procedures (including plant genetically modified micro-organisms storage, removal, destruction, monitoring after the end of the test, the action of accidental releases as well as management of test points) ;

1.5.6 propose specific experimental design based on safety evaluation requirements. Declare

2 environmental release requirements

2.1 Project Name: should include the name of the target gene, genetically modified micro-name and code, test where the provinces (municipalities and autonomous regions) the name and the name of the pilot phase of four parts such as transgenic Cry1Ac Jiyin Su cloud NJ8 and Bacillus thuringiensis NY23 in Guangdong environmental release.

2.2 Number of gene transfer experiment microbial strains: a strain should be declared in the book by the same recipient strain, the same target gene, the same gene manipulation obtained, and each transgenic strain should have clear name or number, and corresponds to the intermediate test.

2.3 Experiment site and scale: each test point area no more than 30 acres (typically greater than 4 acres). Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

2.4 test period: a period for environmental release is generally one to two years.

2.5 application release into the environment in general shall provide the following information related accessories: the amino acid sequence of the nucleotide sequence of the target gene

2.5.1 or deduced;

2.5.2 target gene, the vector map and construct genetically modified micro technology roadmap;

2.5.3 recipient strain, a microorganism gene transfer toxicology test report or relevant literature;

2.5.4 tracking and monitoring requirements information; summary report

2.5.5 intermediate pilot phase safety evaluation;

map 2.5.6 test sites;

2.5.7 release into the environment of Practice (including plant genetically modified micro-organisms storage, removal, destruction, monitoring after the end of the test, the action of accidental releases as well as management of test points);

2.5.8 make specific safety assessment according to test requirements design. Declare

3 production test requirements

3.1 Project Name: should include the name of the target gene, genetically modified micro-name and code, test where the provinces (municipalities and autonomous regions) the name and the name of the pilot phase four parts, such as transgenic Cry1Ac Jiyin Su cloud Bacillus thuringiensis NY23 production test in Guangdong province.

3.2 Number of gene transfer experiment microbial strains: a declaration of no more than five books genetically modified microorganism strain (strain), these strains (strain) should be from the same recipient strain, the same target gene, the same obtained by genetic manipulation, and should have a clear name, and with the previous pilot phase corresponds to the name or number.

3.3 Experiment site and scale: environmental release should be approved over the provinces (municipalities and autonomous regions) carried out each test point area larger than 30 acres. Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

3.4 test period: the first application of productive testing period is usually one to two years.

3.5 application for production test shall provide the following general information related accessories: the amino acid sequence of the nucleotide sequence and the deduced

3.5.1 target gene;

3.5.2 target gene technology road map and genetically modified micro-carrier constructed;

3.5.3 testing organization issued by the recipient microorganism, genetically modified micro toxicology test report or relevant literature;



3.5.6 intermediate stages of testing and environmental release safety evaluation summary; copy
3.5.4 environment release stage of the approval of the book;

3.5.5 tracking and monitoring information requested report;

3.5.7 GM microorganisms map production and test sites; rules

3.5.8 production test (including plant genetically modified micro-organisms storage, removal, destruction, testing after the monitoring, treatment and management measures for accidental release of experimental points, etc.);

3.5.9 propose specific experimental design based on safety evaluation requirements. Declare

4 security certificate requirements

4.1 Project Name: should include the name of the target gene, several parts of genetically modified micro-organisms and other names, such as genetically Bacillus thuringiensis Cry1Ac Jiyin Su cloud of security certificates NY23.

4.2 of genetically modified micro-organisms should be carried out by the Ministry of Agriculture approved the production test, and to apply a security certificate at the end of the test.

4.3 application security certificates using a general term not exceeding five years.

4.4 application security certificate shall provide the following general information related accessories: the amino acid sequence of the nucleotide sequence of the target gene

4.4.1 or deduced;

4.4.2 target gene, the vector map and construct genetically modified micro-technical route;

copy 4.4.3 environmental release and production test stage of the approval of the book;

4.4.4 middle of testing, environmental release, production of the pilot phase of the summary report safety evaluation;

comprehensive evaluation report 4.4.5 GM microorganisms to human health, the environment and the impact of ecological safety;

4.4.6 plants with class genetically modified microorganisms before domestic and foreign production applications;

4.4.7 plants genetically modified microbial detection, identification method or technology roadmap;

4.4.8 plants genetically modified micro-organisms long-term environmental effects monitoring method;

4.4.9 other relevant information.

Second, animal safety assessment of genetically modified microorganism
(a) animal safety evaluation of genetically modified micro-organisms safety evaluation
1
1.1 recipient microorganism recipient microorganism background information: | ||
1.1.1 scientific name, common name and other names;

1.1.2 taxonomic status;

1.1.3 test recipient microorganism strain name;
|| | 1.1.4 is natural or artificial cultivation of wild species of bacteria;

1.1.5 origin and the introduction of time;

1.1.6 purposes;

1.1.7 in domestic applications;

1.1.8 to human health or the environment, whether adverse ecological impact occurred;

1.1.9 Historically, the recipient microorganism may evolve into a pest sex;

1.1.10 is there a long record of safe use. Biological characteristics

1.2 recipient microorganism:

1.2.1 growth period and generation time;

1.2.2 Reproduction and reproductive capacity;
|| | 1.2.3 suitable growth of the nutritional requirements;

1.2.4 application suitable animal species;

1.2.5 colonization in the environment, survival and spread expansion, ability and factors;

1.2.6 pathogenic to animals, whether or produce toxic substances;

1.2.7 on human health and plants potentially dangerous;

1.2 .8 other important biological properties.

1.3 receptors microorganisms to adapt to ecological environment:

1.3.1 domestic geographic distribution and natural habitats, its natural distribution is due to changes in certain conditions change; || | ecological environment
1.3.2 required for growth and development, including temperature, humidity, pH, light, air, etc;

1.3.3 whether specific ecology, such as adaptability in the environment etc;

1.3.4 ecological relationships ecosystems and other micro-organisms, whether by human and animal pathogens (such as a virus) infection. Including changes in the ecological environment of this (these) affect the relationship and whether it will therefore generate or increase adverse effects on animal health, human health and ecological environment;

1.3.5 impact on the ecological environment and the potential degree of risk; when it comes to domestic non usually farmed animal species, the animal should be detailed natural habitats and other relevant information described

1.3.6.

1.4 recipient microorganism genetic variation:

1.4.1 Genetic stability;

1.4.2 plasmid situation, stability and the degree of potential risk plasmid; | ||
1.4.3 transposons and transposable elements and their potential health risk level;

1.4.4 Are there genetic variation and the occurrence of animal health, human health or adversely affect the ecological environment the possibility;

1.4.5 under natural conditions and other microorganisms (particularly pathogens) the possibility of genetic material exchanged;

1.4.6 under natural conditions and animal genetic material exchange possibilities. Monitoring

1.5 recipient microorganism and the possibility of monitoring.

Additional information 1.6 recipient microorganism.

1.7 recipient microorganism determine the level of security in accordance with Article XI of this approach relevant standards. Safety Assessment

2 gene manipulation
2.1 with the introduction of genetically modified animals or microorganisms described modified traits and characteristics.


2.2 actually inserted or deleted sequence data:

2.2.1 insert size and structure of the sequence analysis method to determine its characteristics; 2.2.2

size and function of the deleted region ; amino acid sequence of the nucleotide sequence and the deduced

2.2.3 target gene;

2.2.4 insert copy number sequences.

2.3 of the target gene and vector maps, the carrier's name and the source, vehicle characteristics and safety, can not contain micro-organisms in nature to the transfer of such genes.

2.4 vector fragment was inserted into the region's Information:

2.4.1 Start the name promoter and terminator of size, function and donor organism;

2.4. name size 2 marker gene and reporter gene function and donor organism;

2.4.3 other expression control sequence name their sources (such as artificial or donor organism name).

2.5 genetic manipulation methods.

Stability 2.6 expression of the gene.

2.7 technology for detecting and identifying the gene of interest.

2.8 recombinant DNA molecule structure, replication characteristics and safety.

2.9 to determine the safety of this type of genetic manipulation in accordance with Article 12 of the relevant standard.

3 animals with genetically modified micro-organisms safety evaluation
3.1 The biological characteristics of the animal gene microorganisms; application purposes; ability to survive in nature; the ability to transfer genetic material to other organisms and the likely consequences; monitoring methods and the possibility of monitoring.

3.2 Mechanism of animals genetically modified micro-organisms and animal safety.

3.2.1 prospects for survival in the target animals and non-target animals.

3.2.2 on possible non-target animals and target animals high doses after inoculation.

3.2.3 Compared with traditional products, its relative safety.

3.2.4 drift of host range and carrier.

3.2.5 immunized animals and detoxification ability to communicate in contact with the target and non-target animals, the animals.

3.2.6 animal genetically modified micro-organisms respond to reversion of virulence when passaged ability.

3.2.7 pregnant animal safety.

3.2.8 offspring immunized animal safety.

3.3 animals with genetically modified microorganism on human security.

3.3.1 The possibility of human exposure and risk, it is possible to produce a direct impact on short-term impact and long-term effects, adverse effects arising from the elimination of ways. Potentially dangerous

3.3.2 widely after.

3.4 animals with genetically modified micro-ecological environment security. Range

3.4.1 release in the environment, the range of possible effects on the environment and the presence of which factors.

3.4.2 affect animal genetically modified microorganism survival, proliferation and spread of physical and chemical factors.

3.4.3 target animals infected or potentially dangerous possibilities.

3.4.4 animals genetically modified micro stability, competitiveness, viability, variability and pathogenicity whether due to changes in ambient conditions change.

3.5 animal gene transfer technology for detecting and identifying microorganisms.

3.6 determine animal genetically modified micro level of safety in accordance with Article 13 of the relevant standards.

4 animal safety evaluation of genetically modified micro-organisms genetically modified products
4.1 microbial products stability. On the safety of genetically modified micro-organisms

4.2 production and processing activities.

4.3 genetically modified micro-organisms difference microbial products in terms of environmental safety and turn.

4.4 of genetically modified micro-organisms and products of genetically modified micro-organisms to differences in terms of human health effects.

4.5 Referring to Article 14 of the related standards for animals genetically modified microorganism product level of security.

(Ii) animal microbiological testing program transgenic

1
1.1 provides test site test site meteorological data, a general description of the terrain environment test sites, test sites indicated schematic .

Ecotype 1.2 testing ground around it.

1.3 of animal species around the test site. The possibility of the survival of the ecological environment

1.4 test site on the animal genetically modified micro-organisms, reproduction, diffusion and dissemination of favorable or unfavorable factors, notably the environment, other organisms to obtain the desired gene from the animal genetically modified micro-organisms .

2

2.1 test pilot program beginning and ending time.

2.2 animals with genetically modified micro name or number.

2.3 genetically modified micro-organisms in animal experimental animals the size of each test site.

Size 2.4 test area.

2.5 animals with genetically modified micro applications.

2.6 animals with genetically modified micro production, packaging and transportation to the testing ground mode.

2.7 animals turn to use and dosage modified micro-organisms, and disposal of the unused portion.

3 security controls 3.1
security isolation test animals.

3.1.1 Isolation mode, isolation distance. Measures animal genetically modified micro-organisms to prevent the spread of

3.1.2.


3.1.3 Feeding security controls the whole process. Emergency measures accidents occur

3.1.3 during the test. After treatment

3.2 test animal breeding and testing.

3.3 test after the end of the test site control measures.

After 3.4 years of trial monitoring.

3.5 Monitoring test leaders and contact information. Report

(c) the animals at all stages of genetically modified micro-organisms reporting requirements

1 intermediate test requirements

1.1 Project Name: should include the name of the target gene, transgenic animals and micro-organisms product name, (municipalities and autonomous regions) the name and the name of the pilot phase of four test portions of the province, such as the expression of the recombinant pox virus genetically engineered vaccine NDV F gene test in the middle of Jiangsu Province.

1.2 test microorganism transfected genomic material: a book report should be made of the same strain of microorganism receptor (recipient strain no more than 5), the same target gene, the same gene manipulation obtained, and each transgenic strain should have a clear name or number.

1.3 Experiment site and scale: the test should be carried out in the legal base of the unit. Each animal test point scale (upper limit) for the large animals (horses, cows) 20; small animals (pigs, sheep, etc.) 40 (only); poultry (chicken, duck, etc.) 200 feather (only); Fish 2000 . Province where the trial should be clearly (municipalities and autonomous regions), county (city), township and village and coordinates.

1.4 test period: usually one to two years.

1.5 intermediate test report shall provide the following general information related accessories:

1.5.1 amino acid sequence of the target gene nucleotide sequence and the deduced;

1.5.2 Objective gene map and vector construction; map

1.5.3 test sites and test isolation Figure; Practice

1.5.4 intermediate tests (including animal genetically modified micro-organisms storage, transfer destruction, monitoring after completion of the test, the accidental release of action and management, etc.) test point;

1.5.5 experimental design (including key indicators and safety assessment methods and the like, such as genetically modified microorganisms stable , competition, ability to adapt to survive, exogenous gene expression in the target animals and the ebb and flow, etc.). Reporting requirements

2 releases to the environment

2.1 Project Name: should include the name of the target gene, genetically modified micro-organisms and animal product name, test where the provinces (municipalities and autonomous regions) the name and the name of the pilot phase four parts, such as the expression of the recombinant pox virus genetically engineered vaccine NF16 and YF9 environmental release NDV F gene in Jiangsu province.

2.2 test microorganism transfected genomic material: book a return should be made of the same strain of recipient strain, the same kind of target genes and the same kind of genetic manipulation obtained, each strain should have a clear name or numbered and correspond to the middle of the pilot phase.

2.3 Experiment site and scale: the size of each test point test animals (upper limit) for the large animals (horses, cows) 100; small animals (pigs, sheep, etc.) 500 (only); poultry (chicken , ducks, etc.) 5000 Yu (only); 10 000 fish. Province where the trial should be clearly (municipalities and autonomous regions), county (city), township and village and coordinates.

2.4 Test Period: environmental release once the application period is generally one to two years.

2.5 application release into the environment in general shall provide the following information related accessories:

2.5.1 nucleotide sequence and the deduced amino acid sequence of the target gene;

2.5.2 the target gene and vector maps;

2.5.3 provides safety evaluation test summary report of the pilot phase of the intermediate;

2.5.4 toxicology test report (such as acute, subacute, chronic experiments, mutagenic, mutagenicity test, etc.); map

2.5.5 test sites and test isolation Figure;

2.5.6 release into the environment of procedures (including animal genetically modified micro-organisms storage, removal, destruction, monitoring after completion of the test, the accidental release of action and management, etc.) test point;

2.5.7 experimental design (including key indicators and other safety evaluation and research methods, such as stability of genetically modified micro-organisms, competition, ability to adapt to survive, exogenous gene expression in the target animals and the ebb and flow, etc.). Declare

3 production test requirements

3.1 Project Name: should include the name of the target gene, name of GM microorganism, (municipalities and autonomous regions) the name and the name of the pilot phase of four test portions of the province, the expression of recombinant pox virus genetically engineered vaccine NF16 NDV F gene test production in Jiangsu province.

3.2 test microorganism transfected genomic material: book a return no more than five species of animals genetically modified micro-organisms should be from the same recipient strain, the same target gene, the same gene manipulation obtained, and its name should correspond to the pre-trial phase of the names and numbers.


3.3 Experiment site and scale: environmental release should be approved over the provinces (municipalities and autonomous regions) carried out test animals each test point scale (upper limit) for the large animals (horses, cows) 1000; small animals (pigs, sheep, etc.) 10000 (only); poultry (chicken, duck, etc.) 20,000 birds (only); fish 100 000. Province where the trial should be clearly (municipalities and autonomous regions), county (city), township and village and coordinates.

3.4 test period: the first application of productive testing period is generally one to two years.

3.5 application for production test shall provide the following general information related accessories:

3.5.1 nucleotide sequence of the target gene or its deduced amino acid sequence diagram;

3.5 .2 of the target gene and vector map; copy

3.5.3 environment release stage of the approval of the book;

3.5.4 intermediate testing and environmental release safety evaluation test summary report;

3.5.5 food safety inspection reports (such as acute, subacute, and chronic experiments, mutagenic, causing distortion experiments toxicology report);

3.5.6 by monitoring the target gene or animal report to the environment with genetically modified micro-metastases. Location Map

3.5.7 test sites and test isolation Figure; Practice

3.5.8 production test (including animal genetically modified micro storage, removal, destruction, after the end of the trial monitoring, treatment and management measures for accidental release of experimental points, etc.);

3.5.9 experimental design (including key indicators and safety assessment methods and the like, such as the stability of the genetically modified micro-organisms, competition, survival adaptability, exogenous gene expression in the target animals and the ebb and flow, etc.). Declare

4 security certificate requirements

4.1 Project Name: should include the name of the target gene, several parts of genetically modified organism names, such as: the expression of recombinant fowlpox NDV F gene genetically engineered virus the vaccine NF16 security certificate.

4.2 a declaration can only apply for one kind of animal transgenic microorganism, the name should correspond to the pre-trial stage name or number.

4.3 application security certificates using a general term not exceeding five years.

4.4 application security certificate shall provide the following general information related accessories:

4.4.1 nucleotide sequence of the target gene and its deduced amino acid sequence diagram;

4.4. 2 of the target gene and vector maps; molecular detection

4.4.3 identification of the target gene or technical solutions;

4.4.4 recombinant DNA molecule structure, construction method;
| || 4.4.5 a copy of each test stage of the approval of the book;

4.4.6 each test summary report stage safety evaluation tests;

4.4.7 through monitoring, the target gene or transgene report the situation to the transfer of microorganisms in the environment;

4.4.8 stability, competition for survival, adaptation capacity comprehensive evaluation report;

4.4.9 of the report of the impact of non-target organisms;

4.4.10 food safety inspection reports (such as acute, subacute, and chronic experiments, mutagenic, causing distortion experiments toxicology report);

4.4.11 of such transgenic animals microorganisms before domestic and foreign production applications;

other relevant information required 4.4.12 review.

Third, other safety evaluation of genetically modified micro-organisms
(a) safety assessment of genetically modified microorganism other safety evaluation
1
1.1 recipient microorganism recipient microorganism background information:

1.1.1 scientific name, common name and other names;

1.1.2 taxonomic status;

1.1.3 test name recipient strains of microorganisms;

1.1 .4 species is natural or artificial cultivation of wild species;

1.1.5 origin and the introduction of time;

1.1.6 purposes;

1.1.7 in the country the application;

1.1.8 to human health or the environment, whether adverse ecological impact occurred;

1.1.9 Historically, the recipient microorganism evolved into the possibility of harmful organisms;

1.1.10 is there a long record of safe use. Biological characteristics

1.2 recipient microorganism:

1.2.1 growth period and generation time;

1.2.2 Reproduction and reproductive capacity;
|| | 1.2.3 suitable growth of the nutritional requirements;

1.2.4 colonization in the environment, survival and spread expansion, ability and its influencing factors;

1.2.5 to humans and animals pathogenicity, whether to produce toxic substances;

1.2.6 on plant pathogenic;

1.2.7 other important biological properties. Ecological Environment

1.3 recipient microorganism:

1.3.1 domestic geographic distribution and natural habitats, its natural distribution is due to changes in certain conditions change;
| || 1.3.2 growth required habitat conditions, including temperature, humidity, pH, light, air, etc;

1.3.3 whether the ecological environment in part, to farmland soil, vegetation, land, grassland, affecting aquatic environment;

1.3.4 whether specific ecology, such as adaptability in the environment;


1.3.5 and ecosystems of ecological relations with other microorganisms, including the impact of this change on the ecological environment (s) relations and will therefore generate or increased adverse effects on human health and ecological environment; || |
1.3.6 and ecosystems other organisms (plants and animals) of ecological relationships, including the impact of this change on the ecological environment (s) relations and will therefore increase the arising or to human health or ecological environment adverse effects.

1.3.7 degree of risk and its potential impact on the ecological environment;

1.3.8 usual when it comes to domestic non-planting (breeding) plant and animal species, should be a detailed description of the animal ( plant) of natural habitats and information about their natural predators, parasites, and co-competitor organisms.

1.4 recipient microorganism genetic variation:

1.4.1 Genetic stability;

1.4.2 plasmid situation, stability and the degree of potential risk plasmid; | ||
1.4.3 transposons and transposable elements and their potential health risk level;

1.4.4 is there a possibility of genetic variation and adverse effects on human health or the ecological environment;

1.4.5 under natural conditions and other microorganisms (particularly pathogens) the possibility of genetic material exchanged;

1.4.6 under natural conditions plants may exchange genetic material sex;

1.4.7 under natural conditions and the possibility of animal genetic material exchanged. Monitoring

1.5 recipient microorganism and the possibility of monitoring.

Additional information 1.6 recipient microorganism.

1.7 recipient microorganism determine the level of security in accordance with Article XI of this approach relevant standards. Safety Assessment

2 gene manipulation
2.1 of genetically modified micro-organisms introduced or modified traits and characteristics described.

2.2 actually inserted or deleted sequence data:

2.2.1 insert size and structure of the sequence analysis method to determine its characteristics 2.2.2

size of erasing area and function.

2.2.3 nucleotide sequence and the deduced amino acid sequence of the target gene;

2.2.4 insert copy number sequences.

2.3 of the target gene and vector maps; the name of the carrier and the source, vehicle characteristics and safety, can not contain micro-organisms to the nature of such gene transfer.

2.4 vector fragment was inserted into the region's Information:

2.4.1 Start the name promoter and terminator of size, function and donor organism;

2.4. name size 2 marker gene and reporter gene function and donor organism;

2.4.3 other expression control sequence name their sources (such as artificial or donor organism name).

2.5 genetic manipulation methods.

Stability 2.6 expression of the gene.

2.7 technology for detecting and identifying the gene of interest.

2.8 recombinant DNA molecule structure, replication characteristics and safety.

2.9 to determine the safety of this type of genetic manipulation in accordance with Article 12 of the relevant standard.

3 transfer safety assessment of genetically modified microorganism
3.1 of genetically modified micro-biological characteristics; application purposes; ability to survive in nature; the ability to transfer genetic material to other organisms and the likely consequences; monitoring methods and monitoring possibilities.

3.2 of genetically modified micro-organisms to human security.

3.2.1 The possibility of human exposure and risk, it is possible to produce a direct impact on short-term impact and long-term effects, adverse effects arising from the elimination of ways. Potentially dangerous

3.2.2 widely after.

3.3 genetically modified micro-ecological environment security. Range

3.3.1 release in the environment, the range of possible effects on the environment and the presence of which factors;

3.3.2 impacts of genetically modified micro-organisms survival, proliferation and spread of physical and chemical factors; stability

3.3.3 GM microorganisms, competitiveness, viability, variability and pathogenicity whether due to changes in ambient conditions change.

3.4 gene transfer technology for detecting and identifying microorganisms.

3.5 determine the safety class of genetically modified micro-organisms in accordance with Article 13 of the relevant standards.

4 safety evaluation of genetically modified micro-organisms other products of genetically modified micro-organisms
4.1 product stability. On the safety of genetically modified micro-organisms

4.2 production and processing activities.

4.3 genetically modified micro-organisms difference microbial products in terms of environmental safety and turn.

4.4 of genetically modified micro-organisms and products of genetically modified micro-organisms to differences in terms of human health effects.

4.5 Referring to Article 14 of the related standards of other products of genetically modified micro level of security.

(Ii) Other genetically modified micro-testing program

1
1.1 provides test site test site meteorological data, a general description of the terrain environment test sites, indicating the test sites. Fig.

Ecotype 1.2 testing ground around it.

Related species around 1.3 test site.

Survival ecological environment
1.4 test sites of the genetically modified micro-organisms, reproduction, diffusion and dissemination of favorable or unfavorable factors, notably the possibility of other organisms in the environment of the target gene obtained from the genetically modified micro-organisms.

2 experimental design

starting and ending time of the test 2.1.

2.2 of genetically modified micro-organisms name or number.

2.3 of genetically modified micro-scale in the test sites.

Size 2.4 test area.

2.5 of genetically modified micro applications.

2.6 genetically modified micro-production, packaging and transportation to the testing ground mode.

2.7 revolution use and dosage modified micro-organisms, the disposal of unused portion.

3 security controls
security isolation 3.1 Test organisms.

3.1.1 Isolation mode, isolation distance; measures the spread of genetically modified micro-organisms

3.1.2 prevention; safety control measures

3.1.3 testing process;
emergency measures
3.1.4 accidents occur during the test. After treatment

3.2 test organism culture and tests.

3.3 test after the end of the test site control measures.

After 3.4 years of trial monitoring.

3.5 Monitoring test leaders and contact information. Report

(iii) Other genetically modified micro-organisms at all stages reporting requirements

1 intermediate test requirements

1.1 Project Name: should include the name of the target gene, name of GM microorganism, where the test (municipalities and autonomous regions) and the name of the pilot phase of four names of some provinces. Such as: gene transfer ××× ××× (microorganism names) in Henan Province in the middle of the test.

1.2 test microorganism transfected genomic material: a book report should be made of the same strain of microorganism receptor (recipient strain no more than 5), the same target gene, the same gene manipulation obtained, and each transgenic strain should have a clear name or number.

1.3 Experiment site and scale: the test should be carried out in the legal base of the unit. Each test point scale of not more than 100 liters (kg) fermentation product (sample) or no more than 4 acres of land area. Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

1.4 test period: usually one to two years.

1.5 intermediate test report shall provide the following general information related accessories:

1.5.1 nucleotide sequence of the target gene or the amino acid sequence deduced;

1.5.2 the target gene and vector maps;

1.5.4 intermediate test procedures (including genetically modified micro storage, transfer; map

1.5.3 test sites and test isolation Figure destruction, monitoring after the end of the test, the action and the management of accidental release of experimental points, etc.);

1.5.5 experimental design (including key indicators and safety assessment methods and the like, such as genetically modified micro-organisms of stability , competition, ability to adapt to survive, etc.).

2 environmental release reporting requirements

2.1 Project Name: should include the name of the target gene, name of GM microorganism, where the test (municipalities and autonomous regions) and the name of the pilot phase of four names of some provinces. Such as gene transfer ××× ××× (microorganism names) release in Jiangsu Province and Hebei environment.

2.2 test microorganism transfected genomic material: book a return should be made of the same strain of recipient strain, the same target gene, the same gene manipulation acquired its name or number should be in the middle of the pilot phase It corresponds.

2.3 Experiment site and scale: the size of each test point is not more than 1000 liters (kg) [generally greater than 100 liters (kg)] fermentation product (sample) or no more than 30 acres of land area (typically greater than 4 acres ). Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

2.4 Test Period: environmental release once the application period is generally one to two years.

2.5 application release into the environment in general shall provide the following information related accessories:

2.5.1 nucleotide sequence of the target gene or its deduced amino acid sequence diagram;

2.5. 2 of the target gene and vector maps;

2.5.3 provide an intermediate pilot phase safety evaluation test report;

2.5.4 toxicology test report (such as acute, subacute, chronic experiment , mutagenic, mutagenicity test, etc.);

2.5.5 test site location plan and test isolation Figure;

2.5.6 release into the environment of procedures (including genetically modified micro-storage, removal, destruction, monitoring after completion of the test, the accidental release of action and management, etc.) test point;

2.5.7 experimental design (including key indicators and safety assessment methods and the like, such as genetically modified micro-organisms stability, competitiveness, ability to adapt to survive, etc.). Declare

3 production test requirements


3.1 Project Name: should include the name of the target gene, name of GM microorganism, (municipalities and autonomous regions) the name and the name of the pilot phase of four test portions of the province. Such as gene transfer ××× ××× (microorganism names) production test in Shandong Province.

3.2 test microorganism transfected genomic material: a declaration of no more than five books genetically modified microorganism strain (strain), these strains (strain) should be from the same recipient strain, the same target gene, the same obtained by genetic manipulation, and the name should correspond to the pre-trial stage name or number.

3.3 Experiment site and scale: should be carried out in approved environmental release provinces (municipalities and autonomous regions) carried out each test point larger than 1000 liters (kg) fermentation product (sample) or a land area of ​​more than 30 acres . Provincial test site should be clear where the test (municipalities and autonomous regions), county (city), township and village and coordinates.

3.4 test period: the first application of productive testing period is usually one to two years.

3.5 application for production test shall provide the following general information related accessories:

3.5.1 nucleotide sequence of the target gene or its deduced amino acid sequence diagram;

3.5 .2 of the target gene and vector map; copy

3.5.3 environment release stage of the approval of the book; summary report

3.5.4 intermediate stage safety testing and environmental release evaluation test ;

3.5.5 food safety inspection reports (such as acute, subacute, and chronic experiments, mutagenic, causing distortion experiments toxicology report);

3.5.6 by monitoring purposes reporter genes or genetically modified micro-metastases to the environment; map

3.5.7 test sites and test isolation Figure;

3.5.8 Practice for production test (including genetically modified micro-organisms storage, removal, destruction, after the end of the trial monitoring, measures to deal with accidental release of experimental points and management, etc.);

3.5.9 experimental design (including key indicators and safety assessment methods and the like, such as stability of genetically modified micro-organisms, competition, ability to adapt to survive, exogenous gene expression in the target animals and the ebb and flow, etc.). Declare

4 security certificate requirements

4.1 Project Name: should include the name of the target gene, the gene transfer sections microorganism names. Such as: gene transfer ××× ××× (microorganism names) of the security certificate.

4.2 a declaration can only apply for a genetically modified microorganism strain (strain), whose name and number should correspond to the pre-trial phase.

4.3 application security certificates using a general term not exceeding five years.

4.4 application security certificate shall provide the following general information related accessories: the amino acid sequence of the nucleotide sequence of the target gene

4.4.1 or deduced;

4.4.2 target gene technology road map and genetically modified micro-carrier constructed;

4.4.4 middle of testing, environmental release and; photocopy

4.4.3 environmental release and production test stage of the approval of the book production of the pilot phase of the safety evaluation test summary report;

4.4.5 human health, environmental and ecological safety on a comprehensive evaluation report on genetically modified micro-organisms;

4.4.6 class of genetically modified micro-organisms in the general situation of production and application;

4.4.7 GM microorganism detection and identification techniques;

4.4.8 GM microorganisms long-term environmental effects monitoring method;

4.4.9 other relevant information needed for review.

4.5 application security certificate of genetically modified micro-organisms should be carried out by the Ministry of Agriculture approved the production test, and may apply at the end of the test. Appendix Ⅳ


GMOs and product safety control measures
To avoid potential adverse effects of GMOs on human health and ecological environment, specially formulated corresponding to different levels of genetic engineering work security controls.

1
1.1 Laboratory control measures Safety class Ⅰ control measures:

laboratories and operating according to the general biology laboratory requirements.

1.2 Security Level Ⅱ control measures:

1.2.1 Laboratory requirements:

In addition to the same level of safety Ⅰ laboratory requirements, but also require the installation of clean bench with disinfection and disposal of waste autoclave equipment.

1.2.2 Operating Requirements:

In addition to operating the same security level Ⅰ, but also requires:

1.2.2.1 during the operation as much as possible to avoid the generation of aerosols ;

1.2.2.2 in designated areas within the laboratory operations; within

1.2.2.3 to replace the waste in leak-proof, shatterproof containers, and inactivation treatment ;

1.2.2.4 genetic manipulation must be placed at the front should wear uniforms and other clothes, left the lab laboratory; all creatures unrelated

1.2.2.5 and experiment such as insects and prevent rodents entering the laboratory. In the event of harmful target gene, vector, genetically modified organisms and so escape, diffusion accident, should immediately take emergency measures;

1.2.2.6 animals with genetically modified micro laboratory safety control measures should be in line with veterinary biological products The relevant provisions.

1.3 grade Ⅲ safety control measures:


1.3.1 Laboratory requirements:

In addition to the same level of security Ⅱ laboratory requirements, but also requires:

1.3.1.1 Laboratories should be established in the quarantine area and significantly warning signs, should enter the operating room through a special dressing room, has indoor bathing facilities, operating room door should be installed automatic doors wind leaching;

1.3.1.2 laboratory internal walls, floors, ceilings should be smooth , waterproof, leakage and corrosion;

1.3.1.3 window seals;

1.3.1.4 with autoclave facilities; operation should be between

1.3.1.5 equipped with vacuum cycle purification facilities and sewage treatment equipment.

1.3.2 Operating Requirements: In addition to operating the same security level Ⅱ, but also requires:

1.3.2.1 entering the laboratory must be approved by the project leader;

1.3 .2.2 have to change in the locker room before entering the laboratory overalls, gloves and other protective equipment; must shower before leaving the laboratory; not allowed to leave the lab wearing overalls, coveralls must be autoclaved after cleaning;

1.3 .2.3 table immediately after cleaning with disinfection;

1.3.2.4 transferring material containers used must be double, not broken and sealed;

1.3.2.5 used utensils, all laboratory utensils must be sterilized before away from the laboratory;

1.3.2.6 for the genetic manipulation of all living things, personnel management and epidemic materials shall be stored in special containers or facilities.

1.3.3 safety control measures should be reported to the genetically modified organisms safety committee for approval to perform according to their requirements.

1.4 safety class Ⅳ control measures.

In addition to strictly enforce safety class Ⅲ controls its test conditions and processing facilities as well as the test material should be more stringent requirements. Safety control measures should be reported to the genetically modified organisms safety committee for approval to perform according to their requirements.

2 middle of testing, environmental release and production test security control measures
2.1 grade Ⅰ control measures:

using the general biological isolation method, the test is controlled within the required range . Some transgenic crop field isolation distances are shown in Table 1;

2.2 Security Level Ⅱ control measures:

2.2.1 take appropriate isolation measures to control livestock access, room set up network, network enclosures to prevent insects fly into. Aquatic organisms should be controlled in artificial waters, heightening the dam reinforcement, the inlet and outlet set up fences to prevent the escape of aquatic organisms. Ensure that test organisms 10 years not because of severe weather into natural waters;

2.2.2 of tools and related facilities be disinfected after use;

2.2.3 to take certain biological isolation measures as the test selected in the GMO does not hybridize with the biological geographical area;

2.2.4 take appropriate physical, chemical, biological, environmental and scale control measures;

2.2.5 after the end of the test, the residual portion of plants harvested outside should focus on the destruction of fish ponds, corrals and soil should be thoroughly disinfected and treated to prevent GMO residues and survival.

2.3 grade Ⅲ safety control measures:

2.3.1 take appropriate measures to isolate, unrelated persons prohibited, livestock and vehicles from entering. Depending on the purpose of the test chamber is equipped with nets, manual control of factory farming facilities, specialized containers and killing about genetically modified organisms, such as pharmaceutical and equipment;

2.3.2 Tools and disinfection of the facilities in a timely manner. Prevent GMO test area was brought out, the use of herbicides, insecticides, fungicides, rodenticides and eliminate independent test plants, insects, microorganisms and rodents, etc;

2.3.3 to take the most effective biological isolation measures to prevent GMO hybrid of biological and experimental area, transduction, transformation, conjugation or turn the main parasitic parasitic;

2.3.4 adopt strict environmental control measures, such as the use of environmental ( humidity, moisture, temperature, light, etc.) restrict genetically modified organisms and their products outside the test area of ​​survival and reproduction, or the test area is set in the desert, alpine and other areas so that genetically modified organisms can not survive once the escape diffusion;
|| | 2.3.5 strictly control the scale of the test, if necessary, to keep the destruction of genetically modified organisms;

2.3.6 after the test, the residual portion of plants harvested outside should focus on the destruction of fish ponds, corrals and soil etc. should be disinfected and treated to prevent GMO residues and survival;

2.3.7 safety control measures should be reported to the genetically modified organisms safety committee for approval to perform according to their requirements.

2.4 Security Level IV Control Measures:

In addition to strictly enforce safety class Ⅲ controls its test conditions and processing facilities, and test materials should have more stringent requirements. Safety control measures should be reported to the genetically modified organisms safety committee for approval to perform according to their requirements.

2.5 intermediate transfer test animals modified micro-organisms and their products, environmental release and production test of the control measures should comply with the relevant provisions of veterinary biological products.

3 emergency measures
3.1 GMOs diffusion accident, should be immediately closed scene of the accident, identify the cause of the accident, take prompt and effective measures to prevent genetically modified organisms continues to spread, and reported to the authorities.


3.2 that have been adversely affected diffusion region, the area should be temporarily isolate personnel and medical care.

3.3 diffusion region should be tracked to monitor, until there is no danger.

Table 1 Main crops field isolation distance (reference)

name Crop Species crop isolation distance (meters) Isolation Distance (m) Remarks Note

corn Zea mays L. 300 isolation or flowering 25 days

flowering wheat Triticum aestivum 100 or isolate more than 20 days

flowering barley Hordeum vulgare 100 or isolate more than 20 days

Brassica Brassiaca L. 1000 -

cotton Gossypium L. 150 -

rice Oryza sativa L. 100, or more than 20 days flowering isolation

soybean Glycine max (L.) Merrill 100 - || |.
tomato Lycopersicum esculentum Mill 100 -

tobacco Nicotiana tabacum 400 -

sorghum sorghum vulgare Pers 500 -

potato Solanum tuberosum L. 100 -

pumpkin Cucurbita pepo 700 -

clover Trifolium repens 300 -

ryegrass Lolium perenne 300 -

pepper capsicum annum 100 -

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