Microbial blends in the environmental protection

definition Microbial blends in the environmental protection, refer to one or more microbial strains isolated and purified from nature or obtained by modern biotechnology means such as artificial breeding, which are mainly used for the detection, treatment and remediation of water, air, soil and solid waste pollution.
Implemented by Ministry of Ecology and Environment of the People’s Republic of China/Division of Biodiversity Protection (Division of Biosafety Management)
Event Type administrative licensing
Acceptance department Environmental protection administrative departments of provinces, autonomous regions and municipalities directly under the Central Government
Requirements of operators The import and export operators of microbial inoculants for environmental protection shall be legally established enterprises and institutions engaged in the production or use of microbial inoculants, and shall be capable of safe production, use, storage, transportation and emergency disposal of microbial inoculants.

To import microbial inoculants for environmental protection, an application shall be made for obtaining the Environmental Safety Certificate of Microbial inoculants Samples in accordance with the provisions of the Measures for the Administration of Environmental Safety of Microbial inoculants for Import and Export for Environmental Protection, and health quarantine approval and on-site inspection shall be carried out in accordance with the law on the basis of the environmental safety certificate of the samples.

Legal basis Measures for the Administration of Environmental Safety of Microbial Fungi for Environmental Protection (promulgated by Decree No. 10 of the Ministry of Environmental Protection and the General Administration of Quality Supervision, Inspection and Quarantine on April 2, 2010)
Division of labor among regulators (1) The Ministry of Environmental Protection shall supervise and manage the environmental safety of imported and exported microbial inoculants for environmental protection;

(2) The competent administrative departments of environmental protection of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with these Measures, supervise and administer the environmental safety of the import and export of microbial inoculants for environmental protection within their jurisdiction;

(3) The General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) shall uniformly administer the health quarantine supervision and administration of the national import and export of microbial agents for environmental protection;

(4) The entry-exit inspection and quarantine institutions established by the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) in various regions shall exercise health quarantine supervision and administration over the import and export of environmental friendly microbial agents within their jurisdiction.

Environmental Safety Assessment Committee The Ministry of Environmental Protection, together with the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, has established an expert committee on environmental safety assessment of microorganisms for environmental protection, which is responsible for reviewing the environmental safety of microbial inoculants samples. On April 5, 2006, the State Environmental Protection Administration (original) issued a document (HBH [2006] No. 175) designating the Institute of Microbiology of the Chinese Academy of Sciences as the environmental safety assessment unit for the import and export of microbial agents.
Materials required for sample entry (1) A copy of the microbiological agent import contract or letter of intent signed between the import operator and the overseas operator;

(2) Copies of the professional education or qualification certificates of the competent personnel and professional technicians of the import business operators for the production, application and safe operation of microorganisms;

(3) Environmental safety control measures and emergency plans for production, use, storage, transportation and treatment of microbial agents;

(4) Environmental safety certificate of microbial inoculants issued by the competent government department of the exporting country;

(5) Production and application of microbial agents in exporting countries;

(6) The minimum quantity and specification of samples to be imported for testing and environmental safety assessment;

(7) Other evidential materials for the environmental safety of microbial agents.

 

The materials listed in the preceding paragraph shall be in Chinese or in both Chinese and English, in triplicate.

Sample testing and environmental safety assessment Importers shall entrust microbiological testing and environmental safety assessment institutions to test samples and assess environmental safety.

 

The entrusted testing and environmental safety assessment institution shall be a qualified laboratory (GLP) engaged in microbiological research, or a national professional institution recognized by the National Accreditation Service for Conformity Assessment.

Requirements for testing and environmental safety assessment report The inspection and environmental safety assessment report shall include the following contents:

(1) Microbiological detection and identification of microbial agents;

(2) Safety test of microbial agents;

(3) Evaluation of microbial agents;

(4) Hygienic safety evaluation of microbial agents;

(5) Ecological safety assessment of microbial agents and end products;

(6) Evaluation of the production or use environment of microbial agents.

 

The inspection and environmental safety assessment report shall also be attached with the following contents:

(1) Existing environmental safety assessment data of microbial inoculants exporting countries;

(2) Qualification information of testing and environmental safety assessment institutions and their agents.

 

Sample test and environmental safety assessment report in triplicate.

Review comments on environmental safety of microbial agent samples for environmental protection The Review Opinions on Environmental Safety of Microbial Agent Samples for Environmental Protection shall include the following contents:

(1) Whether the main components of the microbial inoculants declared by the import operator are consistent with the testing results of the testing agency;

(2) Whether the microbial agents contain microbial species (groups) that pose a danger or greater risk to human health and the ecological environment;

(3) Whether the microbial inoculants have been produced and used safely in the exporting country;

(4) Whether the project leader and staff have professional education or qualification in microbial production, application and safe operation;

(5) Whether the environmental safety control measures and emergency plans for the production, use, storage, transportation and treatment of microbial agents are feasible.

Examination and approval of entry-exit health quarantine and inspection application The port inspection and quarantine institution shall accept the application for inspection of environmental protection microbial agents on the strength of the Approval Form for Health Quarantine of Entry and Exit Special Goods, carry out on-site quarantine inspection, and send samples to a professional environmental protection microbial agent compliance testing laboratory for inspection according to relevant regulations. Only those passing the compliance inspection and hygiene inspection can be released.
Subsequent supervision Article 25 Import and export operators shall take environmental safety control measures for the production, use, storage, transportation and treatment of microbial agents for environmental protection, and formulate contingency plans for accident disposal.

Importers and exporters shall keep records of the production, use, storage, transportation and disposal of microbial agents for environmental protection.

Article 26 Import and export business operators shall, before January 31 of each year, submit to the competent administrative departments of environmental protection of the provinces, autonomous regions and municipalities directly under the Central Government for the record the environmental safety management of the production or use of microbial agents for environmental protection in the previous year and the import and export plan of microbial agents for environmental protection in the current year.

Article 27 In case of any abnormality in the process of import, export, production or use of microbial inoculants for environmental protection, or if there is a new scientific basis to prove that they pose a hazard to human health and the ecological environment, the Ministry of Environmental Protection shall revoke its Environmental Safety Certificate of Samples of Microbial inoculants for Environmental Protection, supervise the import entities to destroy the microbial inoculants, and notify the General Administration of Quality Supervision, Inspection and Quarantine of the relevant information.

Article 28 The import and export business operators shall file a record with the competent administrative department of environmental protection of the province, autonomous region or municipality directly under the Central Government where the production or use of microbial agents for environmental protection is located. Any change in the location of production or use of microbial inoculants for environmental protection shall be filed with the competent administrative department of environmental protection of the province, autonomous region or municipality directly under the Central Government where the production or use of microbial inoculants is located before and after the change.

Agency service If you need testing and environmental safety assessment services, please E-mail (caowei@jizhun.com.cn) or call (+86-20-81695425) to contact Cao Wei.