Import and export of microbial agents for environmental protection and environmental safety management

    (April 2, 2010, the Environmental Protection Department, the State administration of quality supervision, inspection and quarantine announced as of May 1, 2010, 10th) Chapter I General provisions

    First to enhance microbial agent for import and export of environmental safety management, maintenance of environmental security, in accordance with the People's Republic of China on frontier health and quarantine law and its implementing rules and the People's Republic of China environmental protection law and other relevant provisions, these measures are formulated.

    Second approach applies to the import and export of environmental microorganism environment and safety management.

    Microbial agents for environmental protection in these measures, refers to the natural purification or obtained by means of artificial breeding of modern bio-technology, mainly for water, air, soil and solid waste pollution detection, management and remediation of one or more bacteria.

    Article on import and export of microbial agents for environmental safety and environment management, the implementation of inspection and environmental safety assessment system.

    Microbial agents in the fourth environmental import-export Manager, should be established according to law and engaged in the production of enterprise legal persons or microbial agents, and microbial agents to secure production, use, storage, transport and emergency handling capabilities.

    Imported environmental microbial agents, in accordance with the provisions of these measures shall be applied for access to the microorganism samples environmental safety certification, environmental safety certification and by the samples go through sanitation quarantine examination and approval and site inspection. Fifth Ministry of environmental protection of microbial agent for import and export environmental protection environmental safety supervision and administration.

    The provinces, autonomous regions and municipalities directly under the jurisdiction of Administrative Department of environmental protection in accordance with these measures within the microbial agent for import and export of environmental safety supervision and administration.

    Circular of the State administration of quality supervision, inspection and quarantine of microbial agents for unified management over import and export of environmental supervision and management work of health and quarantine; located in various parts of the State administration of quality supervision, inspection and quarantine for entry-exit inspection and quarantine on the area of microbial agent for import and export of environmental health quarantine supervision and administration.

    Sixth Environmental Protection Department, in conjunction with the State General Administration of quality supervision, inspection and quarantine to set up environmental protection with the Committee of experts on environmental safety assessment of microorganisms responsible for environmental safety assessment of microbial samples.

    Chapter II sample entry

    Seventh article import business operator shall provide microbial agents using the active seat of provinces, autonomous regions and municipalities submit the following materials by the Administrative Department of environmental protection should apply for immigration of microbial agents for environmental samples:

    (A) the importer signed with the foreign operators of microbial agents import contract or copy of the contract;

    (B) the importer executives and technicians have microbial production, application and safe operation of diploma or qualification certificate;

    (C) microbial inoculum production, use, storage, transport, environmental and safety control measures and environmental emergency plans;

    (D) issued by the Government authorities of the exporting country microorganism environment safety certification;

    (E) production and application of microbial agents in the exporting country;

    (F) intended to be imported for testing and environmental safety assessment of the minimum number of samples and specifications;

    (VII) other microorganism environment security information.

    Materials listed in the preceding paragraph, it should be in Chinese or in English and Chinese texts, a set of three copies.

    Eighth of provinces, autonomous regions and municipalities shall be accepted by the Administrative Department of environmental protection import sample applications within 30th of, to review the application materials, materials are available, the content is true, issued by the immigration notice of microbial agents for environmental samples.

    If necessary, the provinces, autonomous regions and municipalities directly under the environmental protection administration authorities may appoint an expert to undertake a technical review, examination and issue the immigration notice environmental microbial samples. Microbial agents for environmental sample notice of entry must indicate the import sample quantity and specification.

    Microbial agents for environmental sample notice of entry in two copies, one for quarantine examination and approval of the sample, number one for environmental safety assessment of sample verification.

    Nineth entry inspection and Quarantine Bureau of microbial agents for environmental sample notice of entry, sample health quarantine approval issued. Sample by sample, health and quarantine port of entry inspection and quarantine agencies approval form, quantity, specifications, packing of the samples for on-site inspection.

    Sample inspection by qualified, is granted.

    Environmental safety assessment of sample chapter

    Tenth Article import operator shall entrust the microbiological testing and environmental assessment agencies to test samples and environmental assessment.

    Entrusted testing and environmental assessment agencies, qualified and should be engaged in research laboratory (GLP), or China National accreditation service for conformity assessment and accreditation of national professional bodies.

    11th samples and environmental safety assessment bodies should be drawn up for the Ministry of environmental protection of the microorganism testing practice for environmental protection and the microbial agents for environmental protection environmental assessment guidelines, the imported microorganism detection and environmental safety assessment, a detailed sample testing and environmental assessment report, and test the authenticity and accuracy of the data and evaluation findings.

    Testing and environmental assessment report should include the following:

    (A) microbiological identification of microbial agents;

    (B) the safety test of microbial agents;

    (C) evaluation of microbial agents;

    (D) the hygienic safety evaluation of microbial agents;

    (E) the microbial agent and evaluation of ecological security of end products;

    (F) production of microbial agents or the use of environmental assessment.

    Testing and environmental assessment report, should also be attached with the following:

    (A) the microorganism exporter of environmental assessment information;

    (B) the qualification testing and environmental assessment agencies and agency information.

    Sample testing and environmental assessment report, a set of three copies.

    12th sample testing and environmental safety assessment after the testing and environmental assessment agency microorganism samples all safe destruction should be, shall not be retained or used for other purposes. 13th the import business operators shall sample the full inspection.

    Testing and environmental safety evaluation institution shall, in accordance with the immigration notice of microbial agents for environmental samples, check the number of samples and specifications; and number of specifications and environmental microbial samples of entry notice inconsistencies in, no detailed sample testing and environmental assessment report.

    The fourth chapter sample environment safety certification

    14th importer, microbial agents for environmental protection activities should be the seat of provinces, autonomous regions, municipalities tests conducted on samples submitted by the competent administrative Department of environmental protection and environmental safety evaluation report.

    15th of provinces, autonomous regions and municipalities directly under the Administrative Department of environmental protection received samples from the import business operators testing and environmental safety assessment of audit reports within 30th of signed audit opinion, together with the application materials, testing and environmental assessment report in triplicate, Ministry of environmental protection.

    Environmental Protection Department within 5 business days from the date of receipt of application materials, documents submitted to the Committee of experts on environmental safety assessment of microorganisms for environmental.

    16th environmental microbiology environmental safety evaluation Expert Committee shall, within 15 working days from the date of receipt of application materials completed reviews, presented the environmental safety assessment of microbial agents for environmental samples, Department of environmental protection.

    17th the environmental safety assessment of microbial agents for environmental samples, should include the following:

    (A) the import notification of microbial agents main ingredient test results are consistent with the testing organization;

    (B) the microbial agents in the presence of the human health and ecological environment of microorganisms risk or high risk (s);

    (C) microbial agents already in the exporting country for the safe production and use;

    (D) project leaders and staff availability of microbial production, application and safe operation of diploma or qualification;

    (E) microbial inoculum production, use, storage, transport and environmental safety control measures and accident emergency plan for disposal is possible.

    18th Ministry of environmental protection under the environmental safety assessment of microbial agents for environmental samples, detection of microorganisms and environmental safety assessment of qualified agents, issued by the environmental safety of microbial agents for environmental samples to prove it.

    The 19th article of the same importers of the same product (project) name of microbial agents, shall apply for the environmental safety of microbial agents for environmental samples to prove.

    Have access to the environmental safety of microbial agents for environmental samples to prove the same microorganism, have more than two goods (project) name should be reported to the Ministry of environmental protection.

    The 20th microbial agents for environmental sample environment safety certification is valid for three years.

    Still imports after the expiry of the microbial agent, importers need to re-apply for the environmental safety of microbial agents for environmental samples to prove it.

    21st no unit or individual is allowed to transfer, forgery, tampering or altering the environmental safety of microbial agents for environmental samples to prove it.

    The fifth chapter approval and entry-exit health quarantine check 22nd article import and export operators in accordance with the provisions of the Special articles for health and quarantine of entry and exit regulations, sanitation quarantine examination and approval application to the inspection and Quarantine Bureau.

    Importers should also provide a certificate from the Ministry of environmental protection of the environmental safety of microbial agents for environmental samples to prove it.

    On granting import and export inspection and quarantine, the immigration special articles issued by the health and quarantine examination and approval form.

    23rd port special articles for health and quarantine of entry and exit inspection and quarantine institutions approval acceptance of microbial agents for environmental inspection and conduct quarantine inspection and sample sent to service in accordance with the relevant provisions of the environmental microbial agents in accordance with test laboratory for testing, inspection and hygiene inspection of compliance, before release.

    24th port inspection and quarantine institutions for first-time inspection of microbial agents for environmental protection, shall, within 20 working days to complete testing; testing has qualified for the first time, testing should be completed within 10 working days.

    The sixth chapter follow-up supervision

    25th article import and export traders shall microbial agents for environmentally friendly production, use, storage, transport, and environment safety control measures, development of emergency response plan for accidents disposal.

    Import and export business operators shall retain microbial agents for environmental production, use, storage, transport and disposal records.

    26th article import and export traders shall before January 31 of each year, last year environmental microorganism or the use of environmental safety management and environmental microbial agent import and export plan for this year, environmental protection administration departments of provinces, autonomous regions and municipalities.

    27th environmental microbial agent used in import and export, production or use in the process, an exception, or if there is new scientific evidence that human health risks and ecological environment, the Environmental Protection Department should revoke the environmental safety of microbial agents for environmental samples to prove to oversee imported units to destroy the microbial agents, and to inform the State administration of quality supervision, inspection and quarantine of the situation. 28th article import and export dealer shall provide the environmental microbial agent production or activities where departments of provinces, autonomous regions and municipalities directly under the environmental protection administration.

    Production of microbial agents for changing environmental or activity is located, should separately to change before and after the change on the production or activity where provinces, autonomous regions and municipalities directly under the Administrative Department of environmental protection for the record changes.

    The seventh chapter penalty

    29th article violation this approach provides, samples detection and environment security evaluation end Hou, not will microbial bacteria agent samples all security destroyed of, by detection and environment security evaluation institutions location province, and autonomous regions, and municipalities environment administrative competent sector ordered corrected; refused to corrected of, can at 10,000 yuan above 30,000 yuan following of fine, and by environmental protection competent sector specified has capacity of units on behalf of destroyed, by needed costs by illegal who bear.

    Testing and environmental assessment agency issues a false sample testing and environmental assessment conclusions, not to proceed with the evaluation of the Department of environmental protection agencies to make samples and environmental safety evaluation report.

    30th to forge or alter the quarantine, permits, inspection and quarantine institutions may give him a warning or a fine of up to 5000 Yuan fine.

    Violation of these measures, transfer, forgery, tampering or altering the environmental safety of microbial agents for environmental samples to prove, or concealing relevant information, the provision of false information by the Environmental Protection Department to repeal of the environmental safety of microbial agents for environmental samples to prove, the inspection and Quarantine Bureau of sanitation quarantine examination and approval form for revoking the immigration special goods constitutes a crime, criminal responsibility shall be investigated according to law.

    31st article violation this approach provides, not properly save microbial bacteria agent production, and using, and storage, and transport and processing records, or not implementation microbial bacteria agent production, and using, and storage, and transport and processing of environment security control measures and accident disposal emergency plans of, by province, and autonomous regions, and municipalities environmental protection administrative competent sector ordered corrected; refused to corrected of, at 10,000 yuan above 30,000 yuan following fine.

    The eighth chapter supplementary articles

    32nd International conventions, bilateral or multilateral agreements, provisions of the law of the importing State and the contract needs to export microbial agents for environmental samples for environmental safety assessment and environmental safety certification, in accordance with the measures the third to fourth chapter Executive.

    33rd article import and export of environmental microorganism related to animal and plant security, should be consistent with the People's Republic of China Law on the entry and exit animal and plant quarantine laws and regulations, and handle the quarantine of entry licence approval.

    Article 34th import operator import application of principal-agent, his agent except as provided in articles submitted to the seventh application materials, should also provide business license agreements with importers, as well as the original.

    Article 35th of the notice of entry of microbial agents for environmental samples and the environmental safety of microbial agents for environmental samples to prove the formatting and content developed by the Environmental Protection Department. 36th these measures come into force on May 1, 2010.