(Promulgated on June 29, 2004 by Decree No.31 of Shanghai Municipal People’s Government)

Article 1 (Purpose)
These Procedures are formulated for the purpose of strengthening the control of environmental safety in the use of microbial inocula, protecting ecological environment and safeguarding the health of human bodies.
Article 2 (Scope of Application)
These Procedures apply to the control of environmental safety in the use of microbial inocula for the purpose of ecological environmental protection and pollution prevention in the limits of this Municipality.
These Procedures do not apply to the use of microbial inocula belonging under genetic modification and to the use of microbial inocula in laboratories in the scope set out in the preceding clause.
Article 3 (Administrative Department)
The Shanghai Municipal Environmental Protection Bureau (hereinafter referred to as SMEPB) is responsible for the control of environmental safety in the use of microbial inocula in this Municipality.
This Municipality’s administrative departments of agriculture, water affairs, city appearance and environmental sanitation, greening, public health, quality supervision, inspection and quarantine, and other relevant administrative departments shall, in accordance with their own functions and duties, coordinate in the implementation of these Procedures.
Article 4 (Licensing System for Environmental Safety)
This Municipality adopts the licensing system for environmental safety in the use of microbial inocula.
A unit that provides microbial inocula (hereinafter referred to as the providing unit) shall obtain a license for environmental safety of microbial inocula (hereinafter referred to as the environment safety license) for microbial inocula the unit provides.
The providing unit, when providing different strains of microbial inocula, shall obtain separate environment safety licenses.
Article 5 (Appraisal of Environmental Safety)
The providing unit shall, before applying for the environment safety license, entrust an appraising agency for microbial inocula environment safety (hereinafter referred to as the environment safety appraising agency) to conduct appraisal of environment safety in respect of the microbial inocula that it provides.
Article 6 (Environment Safety Appraising Agency)
An environment safety appraising agency shall be capable of microbiological taxonomy and assay, characteristic detection and environmental protection studies or evaluation.
An environment safety appraising agency shall, in accordance with the guidelines on appraisal of environment safety in the use of microbial inocula set by the SMEPB, conduct appraisal, and be accountable to the appraisal conclusion it has made.
Article 7 (Detecting Agency)
Relevant detection data in the appraisal of environment safety in the use of microbial inocula shall be issued by a specialized agency that has passed the measurement certification of corresponding items, or that is recognized by the State laboratory.
An environment safety appraising agency that is not in possession of detection capability shall entrust a microbial inocula detection agency that complies with the requirements set out in the preceding clause (hereinafter referred to as the detecting agency) to make detection. The detecting agency shall be accountable to the detection results it gets.
Article 8 (Application for License)
When a providing unit applies for a microbial inocula environment safety license, it shall submit the following materials:
(1) Application letter;
(2) Appraisal report on environment safety;
(3) Materials certifying that the project leader and staff are in possession of specialized knowledge and safe operation knowledge relating to application of microbiological technology;
(4) Letter of commitment to directing the unit that applies microbial inocula (hereinafter referred to as the applying unit) to take safety control measures; and
(5) Emergency predetermined scheme for environment safety control and the handling of accident in respect of microbial inocula application.
With respect to the introduction from abroad of microbial inocula, the sanitation quarantine documentation of special goods that enter or leave the border issued by the State inspection and quarantine administrative competent authorities shall be submitted in addition.
The MEPB shall, within 20 working days of receiving the application, organize relevant experts to make a demonstration and to render a decision of approval in writing and, in the case of refusal, shall give reasons therefor. If the SMEPB cannot render a decision within 20 working days, upon approval of the person-in-charge of SMEPB, the time limit may be extended for another 10 working days to render a decision, but the applicant shall be notified of the reasons for the extension.
Article 9 (Term of License)
The valid term of an environment safety license is three years. Upon expiry of the valid term of an environment safety license, the providing unit, if in need of continuing to provide the microbial inocula, shall, 30 days prior to the expiry of the valid term, make a renewal application to the SMEPB. The SMEPB shall, in accordance with the provisions under Article 8 of these Procedures, examine it and decide whether or not to grant a renewal approval.
Article 10 (Alteration of Relevant Matters)
If the providing unit alters the application scope of microbial inocula, it shall go through the license alteration formalities.
If the providing unit alters the name of the enterprise or the commodity name of the microbial inocula, it shall, within 10 working days of the day of alteration, report to the SMEPB for the record.
Article 11 (Revocation of License)
Where abnormal conditions occur in the use of microbial inocula or where, with the support of new scientific basis and upon demonstration, that there really exists damage to the environment, the SMEPB may order the cessation of the provision and application, and revoke the environment safety license for such microbial inocula.
Article 12 (Reporting the Application for the Record)
Where microbial inocula is applied in such fields as river (lake) improvement, soil restoration, sewage treatment and garbage composting, the applying unit shall, before the application, report to the SMEPB the name of the providing unit, the name of the applying unit, and the strains, quantity, use, application scope and time, and other relevant contents of the applied microbial inocula for the record.
Article 13 (Safety Control Measures of Providing Unit)
The providing unit shall furnish to the applying unit the environment safety control for application of microbial inocula and the predetermined scheme for accident emergency, technically team up with the applying unit to do a good job of environment safety control and emergency treatment in respect of the application of microbial inocula, make follow-up surveys of the application matters of microbial inocula in this Municipality and report annually to the SMEPB on the application conditions of the microbial inocula the providing unit has provided.
Article 14 (Safety Control Measures of Applying Unit)
The applying unit shall use the microbial inocula with an environment safety license and enhance environment safety management in the process of application in accordance with the environment safety control measures set by the providing unit.
Upon discovering that the application of the microbial inocula harms or is likely to harm environment safety, the applying unit shall take effective measures as stipulated by the predetermined scheme for accident emergency to control and eliminate any harm, and forthwith report to and notify the SMEPB and the providing unit.
Article 15 (Supervision and Administration)
The SMEPB shall make regular or irregular supervisions and inspections on the application conditions of microbial inocula, and relevant units shall render cooperation and shall make no refusal or concealment.
The SMEPB shall exercise follow-up checks on the environment safety appraising agency. The SMEPB shall make known to the public the environment safety appraising agency that assumes no responsibility or practices fraud in the process of appraisal, and shall, within three years after the day of investigation and handling, refuse to accept and handle the environment safety appraisal report issued by such agency.
Article 16 (Security Provision)
Staff members of the environmental protection department, experts participating in the demonstration of microbial inocula environment application, environment safety appraising agencies and detecting agencies shall guard the technical secrets of the providing unit.
Article 17 (Legal Liabilities of Providing Unit and Applying Unit)
For any one of the following acts done in violation of the provisions of these Procedures, correction shall be made within a time limit by order of the MEPB, and for failure to make correction by the expiry of the deadline, in the case of the use for non-commercial activity, a fine of between not less than 500 yuan and not more than 1000 yuan may be imposed; and in the case of the use for commercial activity, a fine of between not less than 1000 yuan and not more than 10000 yuan may be imposed:
(1) The providing unit or applying unit refuses to accept on-the-spot inspection by the environmental protection department, or practice fraud when being inspected;
(2) The providing unit, when altering its enterprise name or the commodity name of microbial inocula, fails to report for the record as required; and
(3) The applying unit, when applying the licensed microbial inocula, fails to report for the record as required.
For any one of the following acts done in violation of the provisions of these Procedures, in the case of the use for non-commercial activity, a fine of between not less than 500 yuan and not more than 1000 yuan may be imposed; in the case of the use for commercial activity, a fine of between not less than 10,000 yuan and not more than 30,000 yuan may be imposed; and in the case of damage done to environment, the elimination of any impact shall be ordered.
(1) Arbitrarily providing microbial inocula, or altering the application scope without approval;
(2) The providing unit transfers an environment safety license;
(3) The providing unit fails to submit a report as required on the matters concerning the application of microbial inocula;
(4) The applying unit arbitrarily uses microbial inocula that has not been licensed; and
(5) Where microbial inocula in the process of application causes impacts on the health of human bodies and ecological environment, and the applying unit fails to take any effective measures therefor.
Where the providing unit in the process of applying for an environment safety license conceals relevant matters or furnishes false materials, the MEPB shall dismiss the application or grant no administrative licnese; and the applicant shall not re-apply for the administrative license within one year.
Article 18 (Legal Liabilities of Environment Safety-Appraising Agency and Detecting Agency)
Where an environment safety-appraising agency acts irresponsibly or practises fraud in the process of appraisal in violation of the provisions of these Procedures making the appraisal results inconsistent with the facts, the SMEPB shall impose a fine of between not less than 10,000 yuan and not more than 30,000 yuan.
With respect to relevant illegal acts done by a detecting agency, the quality and technical supervision administrative department shall deal with them in accordance with law.
Article 19 (Miscellaneous)
The providing unit that has obtained an environment safety license before the implementation of these Procedures shall, within 30 days of the effective date of these Procedures, change the environment safety license with the SMEPB.
The applying unit that has conducted the application of microbial inocula for environmental protection in the area of this Municipality before the implementation of these Procedures shall report to the SMEPB for the record within 30 days of the effective date of these Procedures.
Article 20 (Effective Date)
These Procedures shall become effective on August 1, 2004.