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Shanghai Microbial Agents Use Safety Management

Original Language Title: 上海市微生物菌剂使用环境安全管理办法

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(Adopted by the 43rd ordinary meeting of the Government of the Shanghai City on 28 June 2004, No. 31 of the Decree No. 31 of 29 June 2004 on the People's Government of the Shanghai City issued as from 1 August 2004)

Article 1
To strengthen the management of the use of environmental safety by microbicides, protect the ecological environment, guarantee human health and develop this approach.
Article 2
This approach applies to environmental safety management for the use of microbials for the purposes of ecological environmental protection and pollution control within the city.
In the context of the preceding paragraph, the use of microbials belonging to genetic adaptation and the use of microbial agents in laboratories are not applicable.
Article 3 (Management)
The Environmental Protection Authority of the Shanghai City (hereinafter referred to as the Environment Authority) is responsible for environmental safety management of the use of microbials in the city.
In line with their respective responsibilities, the relevant authorities such as the city's agriculture, water, urban congestion of sanitation, greenification, sanitation, quality, testing and quarantine are implementing this approach in a coordinated manner.
Article IV
In this city, microbial agents are employed in environmental safety permits.
Microborganism provided by microbial units (hereinafter referred to as the provision of units) should be granted a licence for environmental safety in microbials (hereinafter referred to as environmental safety permits).
Different microbial varieties are provided by the provision units and environmental safety permits should be obtained separately.
Article 5 (Environmental safety evaluation)
Prior to applying for environmental safety permits, the provision of units should be delegated to the microbial environmental safety evaluation body (hereinafter referred to as the environmental safety evaluation body) to conduct environmental safety evaluation of the microbials provided.
Article 6
The environmental safety evaluation body should have the capacity to identify microbiologically, to detect and evaluate environmental protection studies or evaluations.
Environmental safety evaluation institutions should evaluate the environmental safety evaluation guidelines developed by the Urban Environment Agency and be responsible for their evaluation findings.
Article 7
Microbethroids use relevant testing data in environmental safety evaluations and should be certified by specialized agencies accredited through relevant project measurements or endorsed by national laboratories.
The environmental safety evaluation body does not have the capacity to detect, and should be entrusted with the screening of microbials that meet the conditions set out above (hereinafter referred to as the test body). The testing body should be responsible for the results of its testing.
Article 8
The provision of units to apply for licences for environmental safety for microbial agents shall submit the following materials:
(i) Applications;
(ii) Environmental safety evaluation report;
(iii) Project heads and staff have certified materials for the application of relevant expertise and safe operation knowledge for microtechnologies;
(iv) To guide the commitment of the microbicide application unit (hereinafter referred to as the application unit);
(v) Environmental safety control and accident disposal of microbial agents.
The introduction of microbial agents from abroad should also be submitted to the sanitary sanitary certificate of entry of special items from the National Laboratory Administration.
The Urban Environment Agency shall organize, within 20 working days of the date of receipt of the request, an expert's argument and make a written licence decision and shall not be approved and shall justify the reasons. In 20 working days, the Urban Environment Agency was unable to make a decision, with approval by the head of the Urban Environment Agency, to extend a licence decision for 10 working days, but the reasons for the extension period should be communicated to the applicant.
Article 9
The period of effectiveness of environmental safety permits is three years. The environmental safety licence expires and the provision of units will require the continuation of the microbial agent, which should be submitted to the Urban Environment Agency by 30 years of effectiveness. The Urban Environment Agency shall, after reviewing the provisions of article 8 of this approach, make a decision to grant the extension of the licence.
Article 10
The provision of units to change the scope of the application of microbials should be processed.
The provision of units to change the name of the enterprise or the name of the microbial agent's commodities should be made available to the Urban Environment Agency within 10 working days of the change.
Article 11
Microbethroids are ill-used in use or, with the support of a new scientific basis, have proven environmental hazards, and the Urban Environment Agency may be responsible for halting the provision and application and withdrawing environmental safety permits for this microbode agent.
Article 12
In the areas of governance, soil rehabilitation, sewage treatment, garbage fertilization, the application of microbials should be made available to the Urban Environmental Protection Agency prior to application, the name of the unit, the name of the application unit, the use of the microbials, the quantity, use, application and time.
Article 13
The provision should provide the application units with environmental safety controls and accident emergency preparedness cases for microbicide applications, and work on environmental safety controls and emergency response in the use of microbial agents in a technical manner, as well as a tracking survey of the application of microbial agents in this city, and the application of microbial agents provided by annual reports to the Environment Agency.
Article 14 (Security control measures of the application unit)
The application units should use microbials that have access to environmental safety permits and enhance environmental safety management in the application process, in accordance with environmental safety controls established by the provision of units.
The application of microbials is found to cause or cause harm to environmental safety, and the application units should take effective measures to control and eliminate hazards in accordance with the accident response scenarios and report, inform and communicate to the Urban Environment Agency in a timely manner.
Article 15
The Urban Environment Agency should conduct regular or non-recurrent oversight, inspection of the use of microbial agents, and the relevant units should cooperate and not be denied and concealed.
The Urban Environment Agency should conduct a follow-up review of environmental safety evaluation institutions. Environmental safety evaluation bodies that are irresponsible or false in the evaluation process should be publicized by the Urban Environment Agency and are inadmissible for three years from the date of identification.
Article 16
Environmental sector staff, experts involved in the environmental application of microbials, environmental safety evaluation institutions and monitoring institutions should conservatively provide the technical secrets of the units.
Article 17
In violation of this approach, there are one of the following cases in which the period of time is being converted by the CEPA, which is later uncorrected for non-commercial activities, punishable by a fine of more than 1000 dollars for operating activities; and a fine of up to 1 million dollars for operating activities:
(i) Provide units, application units to refuse access to environmental sector on-site inspections, or to dispense at the time of inspection;
(ii) The provision of units to change the name of the enterprise or the name of the microbial agent's commodities, which is not specified;
(iii) The application of licensed microbials by the application of the application of the application of the licensed microbials is not required.
In violation of this approach, one of the following cases may be fined by more than 500,000 dollars for non-operational activities; for business activities, fines of up to 30,000 dollars for operating activities; and for environmental hazards to eliminate impact.
(i) The provision of microbial agents without authorization, or the extent of self-removal applications;
(ii) Provide units to transfer environmental safety permits;
(iii) The provision of units does not submit reports on the application of microbials as required;
(iv) The use of unlicensed microbial agents by an application cell;
(v) The impact of the application of microbials on human health or the ecological environment, with no effective measures being taken by the application units.
The provision of units conceals information or provides false material in the application of environmental safety permits, and the Urban Environment Agency is inadmissible or does not have administrative licences, and the applicant shall not apply the administrative licence once again within one year.
Article 18
In violation of this approach, the environmental safety evaluation body has made the evaluation unflagging and resulted in a fine of more than 30,000 dollars at the Environmental Protection Agency.
Relevant violations committed by the testing body are dealt with by the quality technician authorities.
Article 19 (Other provisions)
Prior to the operation of this approach, the provision of units has been granted environmental safety permits and should be transferred to the Urban Environment Agency for environmental safety permits within 30 days of the operation of this scheme.
Prior to the operation of this approach, units that have been used for the protection of the environment of microbial agents within the scope of the city should be available to the Urban Environment Agency within 30 days of the date of operation.
Article 20
This approach has been implemented effective 1 August 2004.