What Are Genetically Modified Organisms?

The original source of the term "genetically modified organisms" was English "Transgenic Organisms", because in the 1970s, when recombinant DNA technology (rDNA) was first applied to animal and plant breeding, the conventional approach was to use foreign genes of interest Transplanted into the organism to make it express, so in the early English literature, this kind of organisms transplanted with foreign genes was vividly called "transgenic Organisms", that is, "transgenic organisms".

Chinese name: GMO
Foreign name: transgenic Organisms

Time: 1870s
the way: Exogenous gene of interest transferred into organism

Introduction to GMOs

With the continuous development of molecular biotechnology, especially since the late 1990s, scientists have been able to

GMO Without the introduction of foreign genes, the genetic characteristics of the organism can also be changed by processing, knocking out, shielding and other methods of the organism's own genetic material to obtain the desired characteristics. Under such circumstances, without the introduction of foreign genes, strictly speaking, they can no longer be called transgenes. It is more appropriate and comprehensive to call gene modification, so now Genetically Modified Organisms (GMOs) is used, that is, genes "Modified organisms" to replace the earlier "Transgenic Organisms." Therefore, the concept of genetically modified organisms is now covered by genetically modified organisms. However, because the term "genetically modified" has been generally accepted, and the introduction of foreign genes is still one of the main methods used in molecular breeding in the field of crop breeding, the term "genetically modified organism" is still used today. Based on this, this article continues to use the term genetically modified, but uses it in the sense of genetically modified organisms.

GMOs in China

GMO regulations

China has always been strict in managing genetically modified foods. On July 1, 2002, the Ministry of Health began to implement the "Measures for the Hygienic Management of Genetically Modified Foods", which stipulated that genetically modified foods must be affixed with specific signs to respect consumers' right to know and choose.

GMOs on sale

There are 17 types of genetically modified organisms in 5 categories, which are listed in the GMO identification catalog and sold in the market, and they all need to be identified in China. Genetically modified foods on the market, such as soybean oil, rapeseed oil, and blended oils that contain genetically modified ingredients, have been identified. Consumers can identify them only by making a careful inquiry when purchasing. ^[1]

GMO species

There are hundreds of genetically modified organisms cultivated by genetically modified technology. Some of them are used to produce pharmaceutical vaccines and biological agents; some are used to produce cellulase and rennet in the food industry; some are used to Eliminate environmental pollution; there are many genetically modified organisms that have played an important role in agricultural production ^[2] .

GMO practices

The usual method is to extract gene fragments with special functions from an organism and add them to the target organism through gene technology. Genetically modified crops are not much different from natural crops in appearance and taste, but some genetically modified crops are supplemented with genes that enhance nutrients, while others can adapt to harsh natural environments and improve yield and quality.

Genetically modified organisms, that is, organisms whose DNA has been artificially modified for specific purposes. The usual method is to extract gene fragments of a certain organism with special functions (such as resistance to diseases and insect pests, increase nutritional components), and add them to the target organism through genetic technology. Based on the development of genetic engineering and synthetic biology in systems biology, artificial design, synthetic genes and transgenic technology have enabled the transfer of transgenes from a single gene to a multi-gene, gene regulatory network, and even an era of transgenic system biotechnology.

GMO prospects

Transgene affects animal traits. If the transgene can be passed on to offspring, it will form a transgenic animal line or herd. Since the birth of transgene, it has been a hot spot in life science research and discussion. With the continuous deepening of research and the continuous improvement of experimental technology, transgene technology has been more widely used. Almost every year, remarkable research results are reported. The genetically modified achievements have entered the development stage of practicality and commercialization ^[3] .

GMO Safety Regulations

GMO Directory

Chapter I General Provisions Chapter II Research and Experiment

Chapter III Production and Processing

Chapter IV Business

Chapter V Import and Export

Chapter VI Supervision and Inspection

Chapter VII Penalties

Chapter VIII Supplementary Provisions

Genetically modified organisms

Article 1 These Regulations are formulated in order to strengthen the safety management of agricultural genetically modified organisms, ensure human health and the safety of animals, plants and microorganisms, protect the ecological environment, and promote the research of agricultural genetically modified biotechnology.

Article 2 : Research, experimentation, production, processing, operation and import and export of agricultural genetically modified organisms within the territory of the People's Republic of China must comply with these regulations.

Article 3: The term "genetically modified agricultural organisms" as used in these Regulations refers to the use of genetic engineering techniques to change the composition of the genome, and the animals and plants, microorganisms, and products used in agricultural production or agricultural product processing, mainly including:

A genetically modified animal and plant (including seeds, breeding livestock and poultry, aquatic seed) and microorganisms;

Second, genetically modified animals and plants and microbial products;

Direct processing of three genetically modified agricultural products;

4. Products containing seeds of genetically modified animals and plants, microorganisms or their products, breeding livestock and poultry, aquatic seeds, pesticides, veterinary drugs, fertilizers and additives.

The safety of agricultural genetically modified organisms referred to in these Regulations refers to the prevention of the dangers or potential risks posed by agricultural genetically modified organisms to human beings, animals and plants, microorganisms, and the ecological environment.

Article 4 The competent agricultural administrative department of the State Council is responsible for the supervision and management of the safety of agricultural genetically modified organisms across the country.

The competent agricultural administrative departments of local people's governments at or above the county level are responsible for the supervision and management of agricultural genetically modified organisms in their respective administrative areas.

The health administrative departments of the people's governments at and above the county level are responsible for the supervision and management of the health and safety of genetically modified foods in accordance with the relevant provisions of the Food Sanitation Law of the People's Republic of China.

Article 5: The State Council establishes an inter-ministerial joint meeting system for the safety management of agricultural genetically modified organisms.

The inter-ministerial joint meeting on the safety management of agricultural genetically modified organisms is composed of the heads of relevant departments of agriculture, science and technology, environmental protection, health, foreign trade, inspection and quarantine, and is responsible for studying and coordinating major issues in the safety management of agricultural genetically modified organisms.

Article 6: The state implements a hierarchical management evaluation system for the safety of agricultural genetically modified organisms.

Agricultural genetically modified organisms are classified into four grades , , , and according to their danger to humans, animals and plants, microorganisms, and the ecological environment. Specific division criteria shall be formulated by the competent agricultural administrative department of the State Council.

Article 7: The state establishes a safety evaluation system for agricultural genetically modified organisms.

The standards and technical specifications for the safety assessment of agricultural genetically modified organisms shall be formulated by the agricultural administrative department of the State Council.

Article 8: The state implements a labeling system for agricultural genetically modified organisms.

The catalog of agricultural genetically modified organisms subject to labeling management shall be formulated, adjusted and published by the agricultural administrative department of the State Council in consultation with the relevant departments of the State Council.

GMO Research and Experiment

Article 9 The competent agricultural administrative department of the State Council shall strengthen the safety evaluation and management of agricultural genetically modified organisms research and experimentation, and set up an agricultural genetically modified organisms safety committee to be responsible for the safety evaluation of agricultural genetically modified organisms.

The Agricultural Genetically Modified Biological Safety Committee is composed of experts engaged in agricultural genetically modified organisms research, production, processing, inspection and quarantine, and health and environmental protection.

Article 10: The competent agricultural administrative department of the State Council may, according to the needs of the safety assessment of agricultural genetically modified organisms, entrust a technical inspection institution with detection conditions and capabilities to carry out the detection of agricultural genetically modified organisms.

Article 11 Units engaged in agricultural genetically modified organism research and experimentation shall have safety facilities and measures appropriate to the safety level to ensure the safety of agricultural genetically modified organism research and experimentation, and establish an agricultural genetically modified organism safety team to be responsible for agricultural genetically modified organisms in their units. Safe work in biological research and testing.

Article 12: Those who are engaged in the research of agricultural genetically modified organisms of grades III and IV shall report to the agricultural administrative department of the State Council before the research begins.

Article 13: The test of agricultural genetically modified organisms shall generally pass through three stages of intermediate test, environmental release and productive test.

Intermediate test refers to a small-scale test performed in a control system or under controlled conditions.

Environmental release refers to a medium-scale test carried out by taking corresponding safety measures under natural conditions.

Productive tests refer to large-scale tests performed before production and application.

Article 14: After agricultural genetically modified organisms are transferred to an intermediate test after the laboratory research is completed, the test unit shall report to the agricultural administrative department of the State Council.

Article 15 If agricultural GMO testing needs to be transferred from the previous testing stage to the next testing stage, the testing unit shall submit an application to the competent agricultural administrative department of the State Council; if the safety assessment is carried out by the Agricultural GMO Safety Committee, the State Council s agricultural administration The competent authority approved the transfer to the next trial phase.

When submitting an application in the preceding paragraph, the test unit shall provide the following materials:

A safety level of agricultural genetically modified organisms and the basis for determining the safety level;

Test report issued by agricultural genetically modified biotechnology testing agency;

Three corresponding safety management and preventive measures;

Four test reports from the previous test phase.

Article 16 (1 ) After a productive test is completed, a unit engaged in the test of agricultural genetically modified organisms may apply to the agricultural administrative department of the State Council for a certificate of safety of agricultural genetically modified organisms.

When submitting an application in the preceding paragraph, the test unit shall provide the following materials:

A safety level of agricultural genetically modified organisms and the basis for determining the safety level;

Test report issued by agricultural genetically modified biotechnology testing agency;

Summary report of three productive tests;

4. Other materials specified by the State Council s agricultural administrative department; After receiving the application, the State Council s agricultural administrative department shall organize the Agricultural Genetically Modified Biosafety Committee to conduct a safety evaluation; only those who pass the safety evaluation may issue an agricultural genetically modified organism safety certificate.

Article 17 Seeds of genetically modified plants, breeding livestock and poultry, and aquatic seedlings, seeds produced from agricultural genetically modified organisms or containing agricultural genetically modified organism components, breeding livestock and poultry, aquatic seedlings, pesticides, veterinary drugs, fertilizers and additives, etc. Before carrying out the examination, registration, evaluation or examination and approval of the relevant laws and administrative regulations, an agricultural genetically modified organism safety certificate shall be obtained in accordance with the provisions of Article 16 of these regulations.

Article 18: Chinese-foreign cooperation, joint ventures, or wholly foreign-funded research and testing of agricultural genetically modified organisms in the territory of the People's Republic of China shall be approved by the agricultural administrative department of the State Council.

Production and processing of genetically modified organisms

Article 19 For the production of seeds of genetically modified plants, breeding livestock and poultry, and aquatic seedlings, a production license for seeds, breeding livestock and poultry, and aquatic seedlings issued by the competent agricultural administrative department of the State Council shall be obtained.

Production units and individuals applying for production licenses for genetically modified plant seeds, breeding livestock and poultry, and aquatic seedlings shall meet the following conditions in addition to the conditions stipulated by relevant laws and administrative regulations:

1. Obtain the safety certificate of agricultural genetically modified organisms and pass the variety approval;

Planting or breeding in designated areas;

There are corresponding safety management and preventive measures;

4. Other conditions stipulated by the competent agricultural administrative department of the State Council.

Article 20 Units and individuals producing seeds of genetically modified plants, breeding livestock and poultry, and aquatic seedlings shall establish production files, stating production locations, genes and their sources, methods of genetic modification, and the flow of seeds, breeding animals, poultry, and aquatic seedlings And so on.

Article 21 Units and individuals engaged in the production and processing of agricultural genetically modified organisms shall be approved by the agricultural administrative department of the State Council or the agricultural administrative department of the people's government of a province, autonomous region, or municipality directly under the Central Government. The specific measures shall be formulated by the competent agricultural administrative department of the State Council.

Article 22 For farmers breeding and planting genetically modified animals and plants, the sales unit of seeds, livestock, poultry, and aquatic seedlings shall comply with these regulations.

The provisions of Article 21 shall handle the examination and approval procedures on behalf of the applicant. Approval departments and agencies shall not charge farmers for approval and agency fees.

Article 23 Units and individuals engaged in the production and processing of agricultural genetically modified organisms shall organize production and processing in accordance with the approved varieties, scopes, safety management requirements and corresponding technical standards, and regularly report to the agricultural administrative department of the county-level people's government in the locality Provide reports on production, processing, safety management and product flow.

Article 24. When a genetic safety accident occurs in the production and processing of agricultural genetically modified organisms, the production and processing units and individuals shall immediately take safety remedial measures and report to the agricultural administrative department of the county-level people's government in the locality.

Article 25 : Units and individuals engaged in the transportation and storage of agricultural genetically modified organisms shall adopt security control measures appropriate to the safety level of agricultural genetically modified organisms to ensure the safety of the transportation and storage of agricultural genetically modified organisms.

GMO Management

Article 26 Units and individuals dealing in seeds of genetically modified plants, breeding livestock and poultry, and aquatic seedlings shall obtain business licenses for seeds, breeding livestock and poultry, and aquatic seedlings issued by the competent agricultural administrative department of the State Council.

Business units and individuals who apply for business licenses for genetically modified plant seeds, breeding livestock and poultry, and aquatic seedlings shall meet the following conditions in addition to the conditions stipulated by relevant laws and administrative regulations:

First, there are special managers and business files;

There are corresponding safety management and preventive measures;

3. Other conditions stipulated by the competent agricultural administrative department of the State Council.

Article 27. Units and individuals dealing in seeds of genetically modified plants, breeding livestock and poultry, and aquatic seedlings shall establish management files that specify the source, storage, transportation, and sales of seeds, breeding poultry, and aquatic seedlings.

Article 28. The sale of agricultural genetically modified organisms listed in the list of agricultural genetically modified organisms in the territory of the People's Republic of China shall be clearly marked.

The agricultural genetically modified organisms listed in the agricultural genetically modified organisms catalogue shall be identified by the production and packaging units and individuals; if they are not identified, they shall not be sold. Business units and individuals should verify the goods and logos when they purchase goods. Business units and individuals who open the original packaging for sale shall be re-labeled.

Article 29 The identification of agricultural genetically modified organisms shall clearly indicate the names of the main raw materials containing genetically modified ingredients in the products; if there are special requirements for the scope of sales, the scope of sales shall also be stated and sold within the designated range.

Article 30 : Advertisements for agricultural genetically modified organisms shall be published, broadcast, set up and posted only after they have been examined and approved by the agricultural administrative department of the State Council.

Import and export of genetically modified organisms

Article 31. Where agricultural genetically modified organisms are imported from outside the People's Republic of China for research and experimentation, the importing unit shall apply to the agricultural administrative department of the State Council; the agricultural administrative department of the State Council may only approve if it meets the following conditions:

One has the qualifications required by the agricultural administrative department of the State Council;

2. The imported agricultural genetically modified organisms have been researched and tested abroad (foreign);

Third, there are corresponding safety management and preventive measures.

Article 32 Overseas companies export genetically modified plant seeds, breeding livestock and poultry, and aquatic seeds to the People's Republic of China, and plant seeds, breeding livestock and poultry, aquatic seeds, pesticides, pesticides, For veterinary drugs, fertilizers and additives, applications should be submitted to the competent agricultural administrative department of the State Council; the agricultural administrative department of the State Council can only authorize the entry of test materials and conduct intermediate tests, environmental releases and productive tests in accordance with the provisions of these regulations if the following conditions are met:

An exporting country or region has been permitted to be used for corresponding purposes and put on the market;

The second exporting country or region has proved to be harmless to humans, animals and plants, microorganisms, and the ecological environment through scientific tests;

Third, there are corresponding safety management and preventive measures.

After the completion of the productive test, after passing the safety evaluation and obtaining the safety certificate of agricultural genetically modified organisms, the examination, registration, or evaluation and approval procedures may be completed in accordance with the relevant laws and administrative regulations.

Article 33 Foreign companies exporting agricultural genetically modified organisms to the People's Republic of China for use as raw materials for processing shall submit an application to the competent agricultural administrative department of the State Council; if they meet the following conditions and pass the safety assessment, the agricultural administrative department of the State Council shall issue agriculture GMO Safety Certificate:

An exporting country or region has been permitted to be used for corresponding purposes and put on the market;

The second exporting country or region has proved to be harmless to humans, animals and plants, microorganisms, and the ecological environment through scientific tests;

Three tests by agricultural genetically modified biotechnology testing institutions have confirmed that there is no danger to humans, animals and plants, microorganisms and the ecological environment;

Fourth, there are corresponding safety management and preventive measures.

Article 34 Where agricultural genetically modified organisms are imported from outside the People s Republic of China, or agricultural genetically modified organisms are exported to the People s Republic of China, the importing unit or overseas company shall present the agricultural genetically modified organism safety certificate and relevant approval documents issued by the agricultural administrative department of the State Council. , Apply to the port entry-exit inspection and quarantine institution for inspection; after passing the quarantine inspection, they can apply to the customs for relevant procedures.

Article 35. In the case of transit transfer of agricultural genetically modified organisms in the People's Republic of China, the owner of the cargo shall apply in advance to the national entry-exit inspection and quarantine department; approval may be made for transit transfers and compliance with the relevant laws and administrative regulations of the People's Republic of China.

Article 36 (1 ) The competent agricultural administrative department of the State Council and the national entry-exit inspection and quarantine department shall make a decision on approval or disapproval within 270 days from the date of receipt of the applicant's application, and notify the applicant.

Article 37. When exporting agricultural products to the People's Republic of China outside the country, and the foreign party requires certification of non-GMO agricultural products, the port entry-exit inspection and quarantine agency shall perform testing and issue non-GMO agricultural products certification based on the information of genetically modified agricultural products issued by the agricultural administrative department of the State Council .

Article 38. Imported agricultural genetically modified organisms that do not have an agricultural genetically modified organism safety certificate and relevant approval documents issued by the State Council s agricultural administrative department or that do not match the certificate or approval document shall be returned or destroyed. If imported agricultural GMOs are not labeled in accordance with the regulations, they must be re-labeled before entering the country.

GMO supervision and inspection

Article 39. The competent agricultural administrative department shall have the right to take the following measures when performing supervision and inspection duties:

Inquiry about the units, individuals, interested parties, and certifiers of the research, test, production, processing, operation, or import and export that are being inspected, and ask them to provide certification materials or other materials related to the safety of agricultural genetically modified organisms;

2. Checking or copying relevant archives, books and data of agricultural genetically modified organisms for research, testing, production, processing, operation, or import or export;

3. Require relevant units and individuals to make explanations on issues related to the safety of agricultural genetically modified organisms;

4. Order units and individuals that violate the safety management of agricultural genetically modified organisms to stop illegal acts;

5. Under emergency circumstances, the storage or detention of agricultural genetically modified organisms that are illegally researched, tested, produced, processed, operated or imported or exported.

Article 40 : The staff of the competent agricultural administrative department shall produce law enforcement certificates during supervision and inspection.

Article 41 (1) Relevant units and individuals shall support and cooperate in the supervision and inspection of the agricultural administrative department, and shall not refuse or hinder the supervision and inspection personnel from performing their duties in accordance with law.

Article 42 When agricultural genetically modified organisms are found to be dangerous to humans, animals and plants, and the ecological environment, the agricultural administrative department of the State Council has the right to announce the ban on production, processing, operation, and import, withdraw the agricultural genetically modified organisms safety certificate, and destroy related dangerous animals. Agricultural genetically modified organisms.

GMO penalties

Article 43 (1 ) If, in violation of the provisions of this Regulation, engaged in the research of Grade III or IV agricultural genetically modified organisms or conducted an intermediate test, and failed to report to the State Council s agricultural administrative department, the State Council s agricultural administrative department shall order the suspension of the research or intermediate experiment and make corrections within a time limit.

Article 44 If anyone violates the provisions of these regulations and engages in environmental release or productive testing without approval, who has been approved but fails to take safety management and precautionary measures in accordance with the regulations, or conducts tests beyond the approved scope, the State Council s agricultural administration The competent department or the competent agricultural administrative department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall, in accordance with its functions and powers, order the suspension of testing and impose a fine of 10,000 yuan up to 50,000 yuan.

Article 45 In violation of the provisions of these regulations, after the end of the productive test, the agricultural genetically modified organisms safety certificate has not been obtained, and the agricultural genetically modified organisms have been put into production and application without authorization, the agricultural administrative department of the State Council shall order the production and application to be stopped and shall be imposed. A fine ranging from 20,000 yuan to 100,000 yuan.

Article 46 (1) Anyone who, in violation of Article 18 of these Regulations, engages in the research and testing of agricultural genetically modified organisms without the approval of the competent agricultural administrative department of the State Council, shall be ordered by the competent agricultural administrative department of the State Council to immediately stop the research and testing, and re-examination and approval procedures shall be completed within a time limit.

Article 47 In violation of these regulations, the production or processing of agricultural genetically modified organisms without authorization or the production and processing in accordance with the approved varieties, scope, safety management requirements and technical standards shall be carried out by the agricultural administrative department of the State Council or provinces, autonomous regions, The administrative department of agriculture of the people's government of the municipality directly under the Central Government ordered to stop production or processing, confiscate illegally produced or processed products and illegal income; if the illegal income is more than 100,000 yuan, a fine of more than one to five times the illegal income shall be imposed; If the income or illegal income is less than 100,000 yuan, a fine of 100,000 yuan to 200,000 yuan shall be imposed.

Article 48 In violation of the provisions of these Regulations, the production and management units and individuals of genetically modified plant seeds, breeding livestock and poultry, and aquatic seedlings have not produced and maintained production and management files in accordance with regulations, and shall be the agricultural administrative directors of people's governments at or above the county level According to its authority, the department ordered corrections and imposed a fine of 1,000 yuan to 10,000 yuan.

Article 49 In violation of the provisions of these Regulations, sales units of genetically modified plant seeds, livestock and poultry, and aquatic seedlings who fail to fulfill the obligations of the examination and approval procedures or charge replacement fees in the course of agency shall be ordered by the State Council s administrative department of agriculture to make corrections, A fine of less than 20,000 yuan.

Article 50 If anyone violates the provisions of these regulations and imports agricultural genetically modified organisms without the approval of the competent administrative department of agriculture of the State Council, the competent administrative department of agriculture of the State Council shall order the importation to be stopped and the imported products and illegal income shall be confiscated; the illegal income shall be more than 100,000 yuan If the illegal income is less than 100,000 yuan, or a fine not exceeding 100,000 yuan, the fine shall be imposed.

Article 51 In violation of the provisions of these Regulations, if agricultural GMOs are imported, carried, or mailed without being reported to the port entry-exit inspection and quarantine agency, or if the agricultural GMOs are transferred through the country without the approval of the national entry-exit inspection and quarantine department, they shall be exported from the port. The entry inspection and quarantine agency or the national entry-exit inspection and quarantine department shall punish them in accordance with the relevant provisions of the Entry and Exit Animal and Plant Quarantine Law.

Article 52 In case of violation of these Regulations on the management of agricultural genetically modified organisms, the administrative department of agriculture of the people's government at or above the county level shall, in accordance with its functions and powers, order correction within a time limit, and may confiscate illegally sold products and illegal income, and may be punished 10,000 yuan. A fine above 50,000 yuan.

Article 53 Whoever counterfeits, forges, transfers, or sells relevant certification documents of agricultural genetically modified organisms, the administrative department of agriculture of the people's government at or above the county level shall collect the corresponding certification documents in accordance with its functions and powers, and punish those who have more than 20,000 yuan but less than 100,000 yuan Fines; if a crime is constituted, criminal responsibility shall be investigated according to law.

Article 54 (1) Violating the provisions of these Regulations, in the event of a genetic safety accident in the process of research, test, production, processing, storage, transportation, sale, or import or export of agricultural genetically modified organisms, causing damage, it shall be liable for compensation in accordance with law.

Article 55 If the agricultural administrative department of the State Council or the agricultural administrative department of the people's government of a province, autonomous region, or municipality directly under the Central Government issues a license, agricultural GMO safety certificate, or other approval document in violation of the provisions of these Regulations, or issues a license, agricultural GMO safety Those who fail to perform their duties of supervision and management after the certificate and other approval documents shall be given administrative sanctions according to law to the person in charge directly responsible and other persons directly responsible; if a crime is constituted, criminal liability shall be investigated in accordance with the law.