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Measures for Examination and Approval of Major Crop Varieties

Measures for Examination and Approval of Major Crop Varieties

(Summary description)Order of the Ministry of Agriculture of the People's Republic of China 2016 No. 4 The "Measures for the Approval of Major Crop Varieties" have been reviewed and approved at the 6th Executive Meeting of the Ministry of Agriculture in 2016, and are hereby promulgated, and will come into force on August 15, 2016.

Measures for Examination and Approval of Major Crop Varieties

(Summary description)Order of the Ministry of Agriculture of the People's Republic of China


2016 No. 4


The "Measures for the Approval of Major Crop Varieties" have been reviewed and approved at the 6th Executive Meeting of the Ministry of Agriculture in 2016, and are hereby promulgated, and will come into force on August 15, 2016.

Information
Order of the Ministry of Agriculture of the People's Republic of China
 
 
2016 No. 4
 
 
The "Measures for the Approval of Major Crop Varieties" have been reviewed and approved at the 6th Executive Meeting of the Ministry of Agriculture in 2016, and are hereby promulgated, and will come into force on August 15, 2016.
 
 
 
                    Minister   Han Changfu
 
 
 
                    July 8, 2016
 
Measures for Examination and Approval of Major Crop Varieties
 
Chapter 1 General Provisions
 
Article 1 In order to examine and approve major crop varieties in a scientific, fair and timely manner, these measures are formulated in accordance with the "Seed Law of the People's Republic of China" (hereinafter referred to as the "Seed Law").
 
Article 2 These measures shall apply to the examination and approval of main crop varieties within the territory of the People's Republic of China.
 
Article 3 "The main crops mentioned in these Measures refer to rice, wheat, corn, cotton, and soybeans.
 
Article 4  The competent agricultural department of the people's government at or above the provincial level shall take measures to strengthen the supervision and management of variety examination and approval. The competent agricultural department of the people's government at the provincial level shall improve the regional cooperation mechanism for the selection, breeding and approval of varieties, and promote the selection and promotion of high-quality varieties.
 
Chapter II Variety Approval Committee
 
Article 5: The Ministry of Agriculture shall establish a National Crop Variety Examination Committee to be responsible for the examination and approval of national-level crop varieties. The competent agricultural department of the provincial people's government has established a provincial crop variety approval committee to be responsible for the approval of provincial crop varieties.
 
The Crop Variety Verification Committee shall establish verification files including application documents, variety verification test data, seed samples, verification opinions and verification conclusions to ensure traceability.
 
Article 6 The Variety Approval Committee is composed of professionals in scientific research, teaching, production, promotion, management, and use. The committee members shall have senior professional titles or positions at or above the division level, and shall generally be under 55 years of age. Each term of office is 5 years, with no more than two consecutive terms.
 
The Variety Approval Committee has 1 director and 2-5 deputy directors.
 
Article 7: The Variety Approval Committee shall establish an office to be responsible for the daily work of the Variety Approval Committee, with 1 director and 1-2 deputy directors.
 
Article 8: The Variety Approval Committee shall set up professional committees according to the types of crops. Each professional committee shall be composed of an odd number of 9-23 persons, with 1 director and 1-2 deputy directors.
 
Provincial Variety Approval Committees may combine to establish professional committees for major crops with small planting areas in their jurisdictions.
 
Article 9: The Variety Approval Committee shall establish a director committee, which is composed of the director and deputy directors of the Variety Approval Committee, the directors of each professional committee, and the director of the office.
 
Chapter III Application and Acceptance
 
Article 10 Units and individuals applying for variety approval (hereinafter referred to as applicants) may directly apply to the National Crop Variety Verification Committee or the Provincial Crop Variety Verification Committee.
 
If foreign institutions and individuals that do not have a habitual residence or business place in China apply for variety approval in China, they shall entrust a domestic seed enterprise with legal personality as an agent.
 
Article 11  Applicants may apply for national or provincial approval alone, or at the same time, apply for national approval and provincial approval, or apply for approval to several provinces, autonomous regions, and municipalities at the same time.
 
Article 12: The variety to be approved shall meet the following conditions:
 
(1) Artificial selection or discovery and improvement;
 
(2) It is obviously different from the existing varieties (other varieties that have been approved or that have been accepted by the Variety Approval Committee at this level);
 
(3) The morphological characteristics are consistent with the biological characteristics;
 
(4) Stable genetic traits;
 
(5) Having a name that complies with the "Agricultural Plant Variety Naming Regulations";
 
(6) A multi-point variety comparison test with more than 2 production cycles in the same ecological type area has been completed. Among them, for those applying for national-level variety certification, there should be no less than 20 comparison tests for rice, wheat, and corn varieties per year, and no less than 10 comparison tests for cotton and soybean varieties per year, or a provincial-level variety certification test result report is available; For the provincial-level variety approval, the variety comparison test shall not be less than 5 points per year.
 
Article 13: Those who apply for variety approval shall submit the following materials to the Office of Variety Approval Committee:
 
(1) The application form, including the type of crop and the name of the variety, the applicant's name, address, postal code, contact person, telephone number, fax, nationality, and the unit or individual for variety breeding (hereinafter referred to as the breeder), etc.;
 
(2) Variety selection report, including parental combination and hybrid parent blood relationship, breeding method, generation and characteristic description; variety (including hybrid parents) characteristic description, standard pictures, suggested test areas and cultivation points; The main defects of the variety and the problems that should be paid attention to;
 
(3) Variety comparison test report, including test varieties, undertaking units, resistance performance, quality, yield results, data of various test points, summary results, etc.;
 
(4) Genetically modified test report;
 
(5) Genetically modified cotton varieties shall also provide agricultural genetically modified organisms safety certificates;
 
(6) Commitment on the authenticity of varieties and application materials.
 
Article 14: The Office of Variety Examination Committee shall make a decision on acceptance or rejection within 45 days after receiving the application materials, and notify the applicant in writing.
 
Those complying with Article 12 and Article 13 of these Measures shall be accepted and the applicant shall be notified to provide test seeds within 30 days. For those who provide test seeds, the office will arrange the variety test. Failure to provide test seeds within the time limit shall be deemed to have withdrawn the application.
 
Those that do not comply with the provisions of Article 12 and Article 13 of these Measures will not be accepted. Applicants can state their opinions or make amendments to the application materials within 30 days after receiving the notice. If they fail to state their opinions or make amendments within the time limit, the application shall be deemed to have been withdrawn; if the amendments still do not meet the requirements, the application shall be rejected.
 
Article 15 The Office of Variety Verification Committee shall retain standard samples from the test seeds provided by applicants and submit them to the Plant Variety Standard Sample Database of the Ministry of Agriculture for storage.
 
Chapter IV Variety Test
 
Article 16 "Variety testing includes the following contents:
 
(1) Regional test;
 
(2) Production test;
 
(3) Variety specificity, consistency and stability test (hereinafter referred to as DUS test).
 
Article 17 The national-level variety regional test and production test are organized and implemented by the National Agricultural Technology Extension Service Center, and the provincial-level variety regional test and production test are organized and implemented by the provincial-level seed management agency.
 
The implementation unit of the variety test organization shall fully listen to the opinions of the variety certification applicants and experts, reasonably set up test groups, optimize the layout of test sites, scientifically formulate test implementation plans, and publish them to the public.
 
Article 18 "Regional tests shall identify the high yield, stable yield, adaptability, and stress resistance of the variety, and conduct quality analysis, DNA fingerprint testing, genetic modification testing, etc.
 
For the regional test of each variety, the test time shall be no less than two production cycles, and the field test design shall be arranged by random block or inter-comparison method. There are no less than 10 test sites in the same ecological type area at the national level and no less than 5 at the provincial level.
 
Article 19: After the completion of the regional test, the production test shall further verify the high yield, stability, adaptability, and stress resistance of the variety in the same ecological type area according to the main local production methods and close to the field production conditions.
 
The number of production test sites for each variety is not less than the regional test sites, the planting area of ​​each variety at a test site is not less than 300 square meters, not more than 3000 square meters, and the test time is not less than one production cycle.
 
For varieties with outstanding comprehensive traits in the first production cycle, the production test can be carried out simultaneously with the regional test in the second production cycle.
 
Article 20  Regional test and production test control varieties shall be certified varieties popularized and applied in the same ecological type area during the same period of production, and shall have good representativeness.
 
The control variety is proposed by the implementation unit of the variety experiment organization, confirmed by the relevant professional committee of the Variety Approval Committee, and replaced in a timely manner according to the needs of agricultural production development.
 
The Provincial Crop Variety Approval Committee shall report the provincial-level regional test and production test control varieties to the National Crop Variety Approval Committee for the record.
 
Article 21 The undertaking unit of regional test, production test, and DUS test shall have independent legal personality, and have stable test land, equipment and technical personnel.
 
Variety testing technicians shall have a college degree or above in relevant majors or a professional technical title above intermediate level, and related work experience in variety testing, and receive relevant technical training on a regular basis.
 
The appraisal of stress resistance shall be undertaken by the appraisal agency designated by the Variety Approval Committee, and the quality test, DNA fingerprint test, and genetic modification test shall be undertaken by a qualified test agency.
 
Units and individuals undertaking variety testing, testing, and appraisal shall be responsible for the authenticity of the data.
 
Article 22 The organization and implementation unit of variety testing shall, in conjunction with the Office of Variety Approval Committee, regularly organize variety testing and inspection, inspect the quality of the test, evaluate the performance of the tested variety, and form an inspection report, and keep on-site pictures of the varieties that show serious defects in the field. material.
 
Article 23 The organization and implementation unit of the variety experiment shall organize the representative of the applicant to participate in the regional test, production test and production test, and the test production data shall be signed and confirmed by the test technician, the person in charge of the test undertaking unit and the representative of the applicant.
 
Article 24  Variety test organization and implementation unit shall hold a variety test summary meeting within 45 days after the end of each production cycle. The Specialty Committee of the Variety Approval Committee shall determine whether the variety shall terminate the test, continue the test, and submit for approval based on the summary results of the test and the results of the test investigation. The Office of the Variety Approval Committee shall promptly notify the applicant of the result of the variety processing.
 
Article 25   If the applicant has the ability to test and the tested variety is its own variety, it may conduct variety testing on its own in accordance with the following requirements:
 
(1) Carry out production trials on its own on the basis of national or provincial-level variety regional trials;
 
(2) If its own varieties belong to special-purpose varieties, regional trials and production trials shall be carried out on their own. The production trials can be combined with the regional trials of the second production cycle. The scope and test requirements of special-purpose varieties shall be determined by the Variety Approval Committee at the same level;
 
(3) If the applicant belongs to a consortium of enterprises, a consortium of science and technology enterprises, and a consortium of scientific research units, organizing and carrying out variety trials in the corresponding districts. The number of members of the consortium should be no less than 5, and relevant cooperation agreements should be signed, clarifying responsibilities and obligations in accordance with the principle of equal rights and equal responsibilities. A legal entity can only participate in one test consortium in the same test area group.
 
The implementation plan for self-development of variety trials in the preceding paragraph shall be reported to the national or provincial variety trial organization and implementation unit within 30 days before sowing, and those that meet the requirements shall be included in the unified management of national or provincial variety trials.
 
Article 26 The DUS test shall be carried out by the applicant independently or by a testing institution authorized by the Ministry of Agriculture, and shall be guided by the Science and Technology Development Center of the Ministry of Agriculture.
 
If the applicant conducts independent testing, the test plan shall be submitted to the Science and Technology Development Center of the Ministry of Agriculture or the provincial seed management agency according to the approved level within 30 days before planting. The Science and Technology Development Center of the Ministry of Agriculture and the provincial seed management agency respectively supervise and inspect the national and provincial DUS testing processes, and conduct random checks to verify the authenticity of samples and test reports.
 
The approximate variety selected for the DUS test should be the variety with the most similar characteristics, and the DUS test is conducted in accordance with the DUS test guidelines for the corresponding main crops. The test report shall be signed by the legal representative or authorized by the legal representative.
 
Article 27: Seed companies that meet the requirements of the Ministry of Agriculture and have obtained a license for combined breeding, production and operation (hereinafter referred to as integrated seed companies for breeding, propagation and promotion) can independently research and develop the main crop varieties in the corresponding ecological zone. For variety testing, submit application materials after completing the testing procedures.
 
The test implementation plan should be reported to the national or provincial variety test organization and implementation unit for the record within 30 days before sowing.
 
An integrated seed enterprise of breeding, reproduction and promotion shall establish an archive of relevant information including the variety selection process, experiment implementation plan, experiment original data, etc., and be responsible for the authenticity of the experiment data, ensure traceability, and accept the agricultural authorities of the people’s government at or above the provincial level. And social supervision.
 
Chapter V Verification and Announcement
 
Article 28 For the varieties that have completed the test procedures, the applicant, the organization implementing the variety test, and the integrated seed breeding and promotion enterprises shall separate the rice, corn, cotton, soybean and wheat varieties by the end of February and September. The test point data, summary results, and DUS test report are submitted to the Office of Variety Approval Committee.
 
The Office of the Variety Approval Committee shall submit the preliminary examination to the relevant professional committee of the Variety Approval Committee within 30 days, and the professional committee shall complete the preliminary examination within 30 days.
 
Article 29: During the preliminary examination of varieties, each professional committee shall convene a plenary meeting, and the meeting shall be valid if the number of members present at the meeting reaches more than two-thirds of the total number of members of the professional committee. For the preliminary examination of the variety, according to the examination standards, a secret ballot is adopted, and the variety with more than one-half of the total number of members of the professional committee shall pass the preliminary examination.
 
The professional committee reviews the variety test data and other materials submitted by the integrated seed breeding enterprises, and those that meet the certification standards shall pass the preliminary review.
 
 Article 30  The challenge system shall be implemented in the preliminary trial. The withdrawal of the director of the professional committee shall be decided by the Office of the Variety Approval Committee; the withdrawal of other members shall be decided by the director of the professional committee.
 
Article 31: For the varieties that have passed the preliminary examination, the Office of the Variety Approval Committee shall publish the preliminary examination opinions, the data of each pilot experiment, and the summary results within 30 days on the official website of the competent agricultural department at the same level, and the publicity period shall not be less than 30 days.
 
Article 32: After the expiration of the publicity period, the Variety Registration Committee Office shall submit the preliminary examination opinions and publicity results to the Director Committee of the Variety Registration Committee for review. The director committee shall complete the review within 30 days. If approved by the review, the review shall be passed.
 
The integrated seed breeding and promotion enterprises carry out their own independent research and development of varieties, and after the varieties are approved, the standard samples of the varieties are submitted to the Plant Variety Standard Sample Library of the Ministry of Agriculture for preservation.
 
Article 33 Varieties that have been approved shall be numbered and issued by the Variety Approval Committee, and announced by the competent agricultural department at the same level.
 
Before the announcement of the crop varieties approved at the provincial level, the agricultural competent department of the provincial people’s government shall submit the name and other information of the variety to the Ministry of Agriculture for publicity. The publicity period is 15 working days.
 
Article 34  The verification number is the abbreviation of the verification committee, the abbreviation of the crop type, the year number, and the serial number, of which the serial number is a four-digit number.
 
Article 35 The contents of the approval announcement include: approval number, variety name, applicant, breeder, variety source, morphological characteristics, growth period, yield, quality, stress resistance, key cultivation techniques, suitable planting areas and matters needing attention, etc. .
 
The provincial-level variety approval announcement shall be reported to the National Crop Variety Approval Committee for the record within 30 days after its issuance.
 
The name of the variety announced in the registration announcement shall be the common name of the variety. It is forbidden to change the common name of the variety without authorization in the process of production, operation and promotion.
 
Article 36  The contents of the examination certificate include: examination number, variety name, applicant, breeder, variety source, examination opinion, announcement number, certificate number.
 
Article 37: For varieties that have not passed the examination, the Office of the Variety Examination Committee shall notify the applicant in writing within 30 days. If the applicant disagrees with the result of the examination, he may, within 30 days from the date of receiving the notification, apply to the original Variety Examination Committee or the National Variety Examination Committee for reexamination. The Variety Approval Committee shall review the reasons for the re-examination, the original approval documents and the original approval procedures during the next approval meeting. If an objection is raised against the identification results of the pests, the Variety Examination Committee shall, if deemed necessary, arrange for another unit to perform the identification again.
 
The Office of the Variety Approval Committee shall notify the applicant in writing of the results of the re-examination within 30 days after the re-examination.
 
Article 38: Variety certification standards shall be formulated by the crop variety certification committee at the same level. The certification standards should be conducive to the improvement and coordination of output, quality, resistance, etc., and the promotion of varieties that meet the needs of the market and daily consumption.
 
Provincial-level variety certification standards should be reported to the National Crop Variety Certification Committee for the record within 30 days after its issuance.
 
When formulating standards for variety certification, public opinions should be solicited.
 
Chapter VI Introduction and Filing
 
Article 39  The competent agricultural department of the people's government at the provincial level shall establish an inter-provincial variety test data sharing and mutual recognition mechanism in the same suitable ecological zone, and carry out introduction and filing.
 
Article 40: If the varieties that have passed the provincial examination and are introduced in other provinces, autonomous regions, and municipalities that belong to the same suitable ecological area, the introducer shall report to the competent agricultural department of the people's government of the province, autonomous region, or municipality for the record.
 
When filing, the introducer should fill in the introduction filing form, including information such as the type of crop, the name of the variety, the name of the introducer, the contact information, the suitable planting area of ​​the approved variety, and the area to be introduced.
 
Article 41: Introducers shall carry out adaptability and disease resistance tests for no less than one year in the area to be introduced, and shall be responsible for the authenticity, safety and adaptability of the variety. For varieties with new plant variety rights, the consent of the owner of the variety rights shall also be obtained.
 
Article 42 The competent agricultural departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall promptly issue an announcement for the record of introduction of species. The contents of the announcement shall include the name of the species, the introducer, the breeder, the examination number, and the suitable planting area for the introduction. The format of the announcement number is: (X) Introduction [X] No. X, where the first "X" is the abbreviation of the province, autonomous region, or municipality directly under the Central Government, the second "X" is the year number, and the third "X" is the serial number .
 
Article 43  The same suitable ecological area for nationally approved varieties shall be determined by the National Crop Variety Approval Committee. The same suitable ecological area for provincial-level approved varieties shall be specifically determined by the provincial-level Crop Variety Approval Committee based on the same suitable ecological area as determined by the National Crop Variety Approval Committee.
 
Chapter VII Revocation of Verification
 
Article 44 In the case of a variety that has passed the examination, the examination shall be revoked if one of the following circumstances exists:
 
(1) There are serious insurmountable defects in the course of use;
 
(2) The species is seriously degraded or loses production and use value;
 
(3) Failure to provide standard samples of varieties as required or the standard samples are untrue;
 
(4) Passing the verification by deceiving, forging test data and other improper methods.
 
Article 45 For the varieties to be revoked, the Office of the Variety Registration Committee shall make suggestions after soliciting the opinions of the applicants for variety approval in writing. After the preliminary examination by the professional committee, it shall be publicized on the official website of the competent agricultural department at the same level. The publicity period shall not be less than 30 day.
 
After the expiration of the publicity period, the Office of the Variety Approval Committee shall submit the preliminary examination opinions and publicity results to the Director Committee of the Variety Approval Committee for review, and the Director Committee shall complete the review within 30 days. If the review agrees to cancel the review, the competent agricultural department at the same level shall make an announcement.
 
Article 46   Announcement of the cancellation of the approval of the variety, the production and advertising shall be stopped from the day when the announcement of the cancellation of the approval is issued, and the promotion and sales shall be stopped after the announcement of the cancellation of the approval for a production cycle. If the Variety Approval Committee deems it necessary, it may decide to stop the promotion and sales from the date of the announcement of the cancellation of the approval.
 
The provincial-level variety revocation announcement shall be reported to the National Crop Variety Registration Committee for the record within 30 days after its issuance.
 
Chapter 8 Supervision and Management
 
Article 47: The Ministry of Agriculture shall establish a national crop variety certification data information system to realize the online application and acceptance of national and provincial varieties certification, variety testing data, certification varieties, cancellation certification varieties, introduction and registration varieties, standard samples and other information interconnection Sharing, unified printing of the certification certificate online. The format of the certification certificate is uniformly formulated by the National Crop Variety Certification Committee.
 
The competent agricultural department of the people's government at or above the provincial level shall release information on variety approval, cancellation of approval, introduction and filing, supervision and management on a unified government information release platform, and accept supervision.
 
Article 48 Variety testing and certification units and staff shall have the obligation to keep confidential the applicant’s business secrets learned during the testing and certification process, and shall not provide seeds for the application for variety certification or seek illegal benefits.
 
Article 49  The members and staff of the Variety Approval Committee shall be loyal to their duties, fair and honest. Members and staff members of the Variety Approval Committee who fail to perform their duties in accordance with the law, engage in fraud or practice favoritism, shall be punished in accordance with the law; they shall not engage in variety approval work within five years from the date when the sanction decision is made.
 
Article 50 Where an applicant commits fraud, bribery and other illegitimate acts in the process of applying for variety approval, his application shall not be accepted within three years.
 
If a consortium member unit engages in fraud, the consortium's variety test approval procedure shall be terminated; the fraudulent member unit shall not apply for variety approval within three years and shall not participate in the consortium test; other member units shall bear joint responsibility and shall not participate in other consortium trials within three years.
 
Article 51: Variety testing, testing, and appraisal institutions that forge test data or issue false certificates shall be punished in accordance with Article 72 of the Seed Law and relevant laws and administrative regulations.
 
Article 52. If an integrated seed breeding enterprise conducts variety trials on its own and applies for verification of fraudulent activities, the agricultural administrative department of the people’s government at or above the provincial level shall impose a fine of one million yuan to five million yuan; Variety testing; if losses are caused to seed users and other seed producers and operators, they shall be liable for compensation in accordance with the law.
 
Article 53 The Ministry of Agriculture shall supervise and inspect the variety approval work of the agricultural competent departments of the provincial people's government. If it fails to carry out variety approval, introduction filing, or cancellation according to the law, it shall be ordered to make corrections within a time limit and be punished in accordance with the law.
 
Article 54 Anyone who violates the provisions of these Measures and constitutes a crime shall be investigated for criminal responsibility in accordance with the law.
 
Chapter 9 Supplementary Provisions
 
Article 55 The working expenses and variety experiment expenses required for crop variety approval shall be included in the special budget of the finance of the competent agricultural department at the same level.
 
Article 56: Measures for the examination and approval of genetically modified crops (excluding genetically modified cotton) varieties shall be formulated separately.
 
Article 57 Varieties that are independently tested by integrated breeding, propagation and promotion enterprises and varieties that are tested by consortiums shall no longer participate in the corresponding block variety test organized by the national and provincial test organizations and implementation units.
 
Article 58 These Measures shall come into force on August 15, 2016. The Measures for the Approval of Major Crop Varieties promulgated by the Ministry of Agriculture on December 27, 2013 (Ministry of Agriculture Order No. 4, 2013) and February 26, 2001 The "Regulations on the Scope of Major Crops" (Order No. 51 of the Ministry of Agriculture) promulgated on Japan will be repealed at the same time.

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