Advanced Search

Administrative Measures On Approval Of Forest Tree Genetic Engineering Activities

Original Language Title: 开展林木转基因工程活动审批管理办法

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
(May 11, 2006 the State forestry administration released 20th come into force July 1, 2006) first in order to regulate the approval of forest tree genetic engineering activities, in accordance with the People's Republic of China administrative licensing law and the administrative examination and approval items really necessary to be retained by the State Council to set administrative licensing decision (State Council Decree No. 412) and relevant regulations of the State, these measures are formulated.
    Article implementation of the administrative licensing of forest tree genetic engineering activities shall abide by these measures.
    Article forest tree genetic engineering activity in these measures, including research, testing, production and management of transgenic trees and import and export activities.
    Transgenic trees in these measures, refers to the use of genetic engineering to alter gene groups, used for forestry or forest product processing plant, including: (a) genetically modified forest plants, (ii) genetically modified forest plant products; (c) the genetically modified forest plants directly processed products; (iv) products containing genetically modified forest plants and components for other related products.
    Fourth security level of forest tree genetic engineering activities in accordance with their humans, animals and plants, micro-organisms and the ecological environment can cause hazard, is divided into the following three categories: level: it is not dangerous; secondary: low hazard; grade III: high risk.
    Forest tree genetic engineering activity specific criteria and evaluation of the security specifications, shall be separately formulated by the State Forestry Bureau.
    Fifth in research and tests of transgenic trees unit, subject to the following conditions: (I) has engaged in research and testing expertise of transgenic trees, (ii) compatible with the research and testing of equipment and facilities.
    Genetically engineered forest trees research and experimentation unit shall establish a transgenic trees safety management organization, is responsible for the safety of the transgenic tree research and test work.
    Sixth engaged in security phase ⅰ and ⅱ study on transgenic trees, research units should be reported to the State Forestry Administration before the study begins.
    Engaged in security grade for III level of GM forest research of, research units should in research began Qian to national forestry Council proposed application, and submitted following material: (a) applications; (ii) forest GM engineering activities of security grade and determine security grade of according to; (three) and security grade phase adapted of security facilities, and security management and prevention measures, situation of description material; (four) location provincial forestry competent sector or tertiary institutions, and Central directly under the research hospital by of audit views. Article seventh test transgenic trees, generally divided into three stages of testing, environmental release and production test. Pilot, refers to a control system or small-scale testing under controlled conditions. Environmental release is under the natural conditions, take appropriate safety measures the scale of testing.
    Productive test, is in the production and application of large-scale testing before.
    Environmental release of transgenic trees and production tests can be conducted in parallel.
    Eighth article GM forest research end Hou, need into middle test of, test units should to national forestry Council proposed application, and submitted following material: (a) applications; (ii) research summary report; (three) forest GM engineering activities of security grade and determine security grade of according to; (four) corresponding of security research content, and security management and prevention measures, situation of description material; (five) location provincial forestry competent sector or tertiary institutions, and Central directly under the research hospital by of audit views.
    Nineth article GM forest Middle test end Hou, need for environment release, or synchronization for environment release and productive test of, and in environment release end Hou need into productive test of, test units should to national forestry Council proposed application, and submitted following material: (a) applications; (ii) forest GM engineering activities of security grade and determine security grade of according to; (three) corresponding of security research content, and security management and prevention measures, situation of description material;
    (D) a summary report of the pilot phase on (v) State Forestry Bureau test report issued by a designated testing body; (vi) the local provincial forestry authorities or universities, Central Research Institute directly under the review comments.
    Article tenth application security phase III study of transgenic trees, or be applied to test transgenic trees, meets the following conditions, shall be approved: (a) has a reliable safety assessment, (ii) meets the requirements of security level security controls, (iii) comply with the conditions laid down in article fifth; (iv) consistent with the provisions of relevant laws and regulations of the State.
    11th article productive test end Hou, need application GM forest security certificate of, test units should to national forestry Council proposed application, and submitted following material: (a) applications; (ii) GM forest of security grade and determine security grade of according to; (three) productive test stage of summary report; (four) location provincial forestry competent sector or tertiary institutions, and Central directly under the research hospital by of audit views; (five) other about material.
    State forestry administration shall organize safety evaluation of applications for safety certificates transgenic trees, qualified security assessment in order to issue safety certificates transgenic trees.
    12th security certificate shall contain the genetically modified transgenic trees forest name, certificate number, size, scope, validity and responsibility, safety control measures, and so on.
    13th for the production and management of genetically modified forest trees shall be obtained safety certificates transgenic trees.
    Production and management of transgenic trees units and individuals shall be in accordance with the requirements of safety certificates transgenic trees is engaged in production and business activities.
    Sales of genetically modified seed, should use clear text annotations, and prompted security control measures.
    14th article intends from outside introduced GM forest for research, and test, and production or business of, should to national forestry Council proposed application, and submitted following material: (a) applications; (ii) imports GM forest security management registration form; (three) intends introduced of GM forest in outside has for corresponding research, and test, and production or business of proved file; (four) introduced process in the intends take of security management and prevention measures.
    Intended to introduce transgenic trees used in the production, operation, shall also submit the exporting country or region after scientific tests found in humans, animals and plants, micro-organisms and the ecological environment of harmful information.
    15th transgenic trees imported from abroad, for research, testing, production, operations, shall be executed in accordance with these regulations.
    16th to the overseas export of forest products, the whole proof of whether transgenic trees is required, the State Forestry Administration can provide relevant materials. 17th article national forestry Council received carried out forest GM engineering activities of about application Hou, on application material complete, and meet statutory form of, should accepted and issued national forestry Council administrative license accepted notice; on not accepted of, should told applicants and description reason, issued national forestry Council administrative license not accepted notice; on application material not align or not meet statutory form of, should in 5th within one-time told applicants need correction of all content, issued
    State Bureau of forestry administrative permit notice of correction material.
    18th National Bureau of forestry administrative licensing decisions are made, need expert verification or designate an testing organizations to test transgenic trees shall be effective as of the date of acceptance in the 10th, issued by the State Bureau of forestry administrative permit required hearings, bidding, auction, testing, inspection, and quarantine, identification and advice of specialists, expert verification and detection time inform the applicant.
    Experts on verification and testing time required before making a decision on the administrative license within the time limit is not evaluated.
    19th national forestry Council shall from the date of acceptance of the decision whether or not to grant an administrative license in the 20th, written decision on approving an administrative license is issued by the National Forestry Bureau or the State Forestry Administration to reject the licensing book and inform the applicant.
    20th cannot make a decision on the administrative license within the statutory time limit in section, approved by the head of the State Forestry Bureau, state forestry administration shall, before the expiry of the statutory time limit of 5 working days to handle State Bureau of forestry administrative permit extension notice, and inform the applicant.
    Article 21st of forest tree genetic engineering activities carried out administrative licensing decision, shall, in accordance with the relevant provisions of public announcement, announcement.
    22nd State Forestry Administration should be carried out in accordance with the licensee conduct supervision and inspection of forest tree genetic engineering activity.
    23rd licensee to deception, bribery or other improper means to obtain approval, the State forestry administration according to law the administrative license revocation of its forest tree genetic engineering activities and publicity, announcement.
    To repeal the decision on the administrative license, the State forestry administration shall inform the licensee in writing and inform their right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.
    24th article violation this approach provides, carried out forest GM engineering activities of, national forestry Council can give warning, has illegal proceeds of, can and at illegal proceeds 1 time times above three times times following and not over 30,000 yuan of fine; no illegal proceeds of, belongs to non-business activities of, can and at 1000 Yuan following fine, belongs to business activities of, can and at 10,000 yuan following fine.
    25th National Board of forestry-related staff approval of forest tree genetic engineering activities in the implementation of administrative licensing, abuse of power, favoritism, and shall be given administrative sanctions in serious cases, constitute a crime, criminal responsibility shall be investigated according to law.
    26th article of forest tree genetic engineering activities carried out 10 copies of relevant written application materials are, and produced in accordance with provisions of the State forestry administration.
                                              27th article this way come into force July 1, 2006.