HJ/T 415-2008Guide of Safety. Assessment on Application of Microbial Blends in the Environmental Protection (English PDF)

3.1 Environmental Microbial agents

It refers to one or more separation and purification from nature, through natural or artificial breeding (without genetic modification) obtained by microbial strains (Strain) composed of applied environmental protection and pollution prevention of microbial agents.

3.2 Gene engineered microbial agents

It means by modern biotechnology (such as. cell fusion, DNA recombination, etc.) by transforming the original genetic structure and function Microbial agents.

3.3 LABORATORY

Manual control means in the Experimental System.

3.4 Structures

Physical barriers or physical means for limiting microbial agents, and to reduce the human and animal health and ecological potential safety hazards, Chemistry, Biology Integrated learning barrier structure.

3.5 Open environment applications

It refers to the application in a natural environment under controlled conditions in the non-human.

3.6 Ecologically sensitive area

It refers to a region of the most intense changes in the ecological environment and ecological problems of the most vulnerable areas, but also sustainable development and the regional ecosystem the key areas of ecological environment comprehensive improvement, including. National Nature Reserve, mountain forests, water sources, large reservoirs, coastal with the natural landscape tourist spots. Ecologically sensitive areas of the region as a whole ecological environment play a decisive role in the event of vandalism will be difficult to have Restorer.

4.1 Evaluation Objective

Analysis and evaluation of environmental microbial agents and use, harmful effects on human and animal health and ecological safety and potential risks;

Develop scientific, effective and feasible prevention, emergency response, mitigation or elimination of measures to promote environmentally safe application of microbial agents.

4.2 Evaluation Principles

HJ/T 415 2008

4.2.1 Environmental Safety evaluation Microbial Community environments should adhere to the principle of correspondence. The purpose of the evaluation, the content and requirements shall be ring Paul corresponds with microbial agents of environmental safety management purpose, content and requirements.

4.2.2 Environmental Safety evaluation of environmental microbial agents should follow the principle of comprehensiveness. The evaluation should involve the use of various microbial agents Links and information about them.

4.2.3 Environmental Safety evaluation Microbial Community environments should adhere to the principle of forward-looking. It should be based on the characteristics of microorganisms, application classes Type, the existing level of evaluation and control of the level of environmental protection with microbial agents and their use may human and animal health and for the environment the potential impact of the risk assessment, and uncertainty described and analyzed in order to facilitate new technologies and data appears, Supplement the evaluation.

4.3 Evaluation Key

Environmental protection with environmental safety assessment of microbial agents should use the following aspects as environmental safety assessment focus.

4.3.1 microbial agents contained in each species (strain) of biological characteristics and pathogenicity.

4.3.2 microbial strains for resistance to commonly used antibiotics resistance (or resistance).

4.3.3 and potential harmful effects of microbial agents and their use in various types of metabolites in human and animal health and possible ecological safety harm.

4.3.4 Use of microbial agents in all sectors of scientific, effective and feasible prevention, emergency response, mitigation or elimination measures.

4.4 Evaluation Program

Environmental microbial agents with environmental safety assessment procedures include. environmental risk identification, evaluation content and focus to identify, evaluate TECHNOLOGY Surgery route planner, special testing reporting, environmental safety assessment, emergency plans for the development, evaluation report writing and so on.

4.4.1 Environmental Risk Identification

Movies should be analyzed and harmful microbial agents and evaluation process of using various types of metabolites in human and animal health and the ecological environment possible Impact and potential hazards, including pathogenicity and toxicity impacts.

4.4.2 Evaluation of content and priority setting

Risk identification should be based on the results to determine the environmental microbial agents safety evaluation of content and focus.

4.4.3 Technical Evaluation route planner

Should be based on safety evaluation of content and focus, select and determine the microbial agent environmental safety assessment strategies and techniques based on road line.

4.4.4 Specific test report preparation

It should be entrusted with relevant qualification units or laboratory pathogenic microbial agents and ecotoxicity impact testing, and submit the relevant Inspection report and raw data.

4.4.5 Environmental Safety Evaluation

Special testing should be based on the report, the declaration of microbial agents in the field of environmental safety assessment.

4.4.6 Emergency plans developed

Should not affect the ecological environment and human and animal health problems Environmental characteristics with microbial agents and the use of various aspects that may occur according to Develop scientific, effective and feasible prevention, emergency response, mitigation or elimination measures.

4.4.7 Evaluation report prepared

We should organize, analyze and research all kinds of basic data and information on the preparation of environmental microbial agents safety evaluation report.

5.1 Evaluation of microbial agents

Microbial agents to master all strains (strains) of composition, origin, geographic distribution and natural habitat and biological characteristics; confirm each species (Strain) of identification and detection techniques for each species (strain) pathology, ecology and physiology traits evaluated.

5.1.1 agents name. Microbial agents specifically evaluated the trade name, subject and object of evaluation is determined.

5.1.2 inoculant composition. Each species clearly constitute microbial agents (strain) components.

HJ/T 415 2008

5.1.3 Each bacterium strain (strain) of origin and classification. A detailed description of the various microbial agents constitute strains (strains) sources and classification feature.

5.1.4 Each bacterium strain (strain) Geographic distribution and natural habitat. A detailed description of each species constitute microbial agents (strain) Geographic Distribution and natural habitat.

5.1.5 inoculant genetic stability of each species (strain). Passage through tests and molecular biology tests, evaluation of Microorganisms Genetic stability, and to determine the possible factors.

5.1.6 Each bacterium strain (strain) of pathology, ecology and physiology traits. Constitute a detailed description of the various strains of microbial agents (Strain) of pathology, ecology and physiology characteristic traits.

5.1.6.1 agents each species (strain) of hazard classification. According enacted "pathogenic microbiology laboratory bio-safety regulations" "Human infection pathogens List" and "animal pathogens classification list" to determine microbial agents constituting the various strains (strains) Microbiological hazards Classification. If no directory inclusion, by the people's government administrative departments of environmental protection at all levels of the organization of expert assessment Trial, and agents of each species (strains) by the assessment report hazard classification.

5.1.6.2 agents each species (strain) survival information. A detailed description of the various microbial agents constitute strains (strains) in ecosystems Survival information, including seasonal forming viable structure.

5.1.6.3 agents each species (strain) reproductive information. A detailed description of the various microbial agents constitute strains (strains) in the ecosystem, Reproduction of information under different environmental conditions.

5.1.6.4 agents each species (strain) pathogenic, toxigenic, allergenic. Genotoxicity tests and information retrieval through biological literature Inquiries and other ways and means to acquire all strains (strains) of pathogenicity, toxigenicity, allergenicity, evaluate its ecological environment and human and animal health safety Full harmful effects that may arise and the potential risks.

5.1.6.5 agents each species (strain) resistance. By microbial agents commonly used clinical antibiotic resistance test (also known as Resistance test), grasp the constituent species (strain) on antibiotic resistance (resistance), to evaluate the ecological environment and human and animal health safety Full harmful effects that may arise and the potential risks.

5.1.7 Each bacterium strain (strain) of identification and detection techniques. In order to facilitate the supervision and management, it requires a detailed description of each species identification technology agents Surgery and detection methods; and in accordance with the characteristics of microbial classification, response sensitivity of each species (strain) identification and detection techniques, confidence (in a given Volume terms) and specificity was confirmed and evaluated in order to improve the accuracy of identification and detection.

5.2 Ecological Security Assessment

Microbial agents and all kinds of end products ecological safety assessment, including ecological toxicity evaluation and hygienic evaluation.

5.2.1 Ecotoxicity Assessment

According microbial agents environment and ultimately discharged form the final product, you can select microbial toxicity test, algal toxicity test Inspection, miniature animal toxicity studies, fish toxicity test, mammalian toxicity test, mutagenicity test and other ecological toxicity tests and Based on this, the final product is completed microbial agents and their ecological toxicity evaluation.

If the final product emissions in ecologically sensitive areas in the region to deal with particular taxa ecological toxicity evaluation Community level.

5.2.2 Hygienic Evaluation

According microbial agents environment and ultimately discharged form the final product, must be carried out on the final product hygienic evaluation.

5.2.2.1 Microbiological end products include indicator bacteria testing and evaluation of the total number of bacteria, fecal coliform and other indicators.

5.2.2.2 served as microbial agents contain pathogenic microorganisms, pathogens shall be carried out on the final product testing and evaluation, the unit body Product types of pathogenic microorganisms, and the number of pathogenic strength.

5.3 Environmental Assessment Information

Environmental health are likely to adversely affect the environment and with the management of microbial agents on the ecological environment and human and animal safety, be required to Microbial agents used within the structures and the use of various types of information such as the safety evaluation in an open environment.

5.3.1 Information provided with the evaluation structures

General Description 5.3.1.1 structures, including material, shape, structure, size and other basic information.

5.3.1.2 structures of microbial agents in feed point (import) and the possible release point (outlet).

HJ/T 415 2008

Placement location and description 5.3.1.3 structures surrounding environment, particularly in ecologically sensitive area around the possible descriptions.

5.3.1.4 structures safe isolation measures.

Procedure 5.3.1.5 microbial agents use and disposal.

5.3.1.6 microbial agent container handling, preservation and disposal procedures.

5.3.1.7 operators work activity status and safety precautions.

Biosafety training programs and records 5.3.1.8 operator.

5.3.1.9 Waste disposal includes final product planning, implementation records.

Emergency plans 5.3.1.10 sudden accident.

5.3.2 Open environment information evaluation

5.3.2.1 purpose and use of the Objective 5.3.2.1.1 open environment, processes, products, etc., and predictable.

5.3.2.1.2 use the date, time and work programs include the use of frequency, duration, and so on.

5.3.2.1.3 using the methods and procedures.

5.3.2.1.4 With placement number, concentration and other parameters.

5.3.2.1.5 use an open environment to interfere with other various activities of non-use purposes.

5.3.2.1.6 Use and all aspects of microbial agents on staff and its protective measures.

Using a processing scheme and disposal plan 5.3.2.1.7 place after use.

5.3.2.1.8 After the end of the use of the method to be adopted to eliminate or inactivated.

5.3.2.1.9 similar work-related information and results.

5.3.2.2 the site environment and background 5.3.2.2.1 use the geographic location and labeling. If necessary, the application of global positioning system (GPS) positioning.

5.3.2.2.2 use to geography, geology and soil science features.

5.3.2.2.3 land use and the impact of climate zones.

5.3.2.2.4 use to the surrounding population density and distribution.

5.3.2.2.5 Use background to the surrounding environment, including the resident status of economic activity based on natural resource use and.

5.3.2.2.6 use to the surrounding flora and fauna features, including crops, livestock and migratory species.

5.3.2.2.7 use with space ecologically sensitive area surrounding important nature reserves, water sources and other distance.

5.3.2.2.8 using the distance with the surrounding humans and other important taxa in physics and biology.

5.3.2.2.9 Affected target ecosystems and non-target ecosystems.

5.3.2.2.10 serving (or release) natural features habitats and compared with serving recommendations or differential release between habitats.

5.3.2.2.11 microbial agents serving regional development planning may have environmental impacts.

Evaluation 5.3.2.3 When using an open environment of interaction with the environment 5.3.2.3.1 microbial agents contained strains (strains) survival, environmental conditions or propagation effects.

5.3.2.3.2 microbial agents contained strains (strains) life cycle in the environment.

5.3.2.3.3 genetic variation in the ability of microbial agents contained after species (strain) into the environment.

5.3.2.3.4 microbial agents contained in the extent of harm after species (strain) into the environment, including host range, pathogenicity, infectious , Toxic, allergic and other effects.

5.3.2.3.5 microbial agents contained bacteria (strain) on the use of indigenous biological community structure damage or change the situation.

5.3.2.3.6 microbial agents contained bacteria (strain) and its metabolites whether it will generate new harmful substances into the environment.

5.3.2.3.7 microbial agents contained bacteria (strain) and whether metabolites will enhance existing hazardous pests into the environment Sex.

5.3.2.3.8 may appear in the biogeochemical cycle or biological cycle other complications.

5.4 Other information evaluation

HJ/T 415 2008

5.4.1 monitoring technology, release control technology, waste treatment and emergency response plans and other technical information evaluation

5.4.1.1 Monitoring Technology

5.4.1.1.1 microbial agents contained strains (strains) of classification and identification of the environmental impact of tracking and monitoring methods.

5.4.1.1.2 Specific monitoring techniques, sensitivity and reliability.

5.4.1.1.3 feasibility of monitoring programs, including the frequency, number of samples, storage, transportation and so on.

5.4.1.2 Trafficking (or release) control technology

5.4.1.2.1 In order to avoid or reduce microorganisms in serving and surrounding area diffusion control technology.

5.4.1.2.2 serving authorization protection methods and procedures (or release) locations.

5.4.1.3 Waste Treatment Technology

5.4.1.3.1 microbial agents use the directory and type in the list of waste, including waste water, waste gas and solid waste Wait.

5.4.1.3.2 accordance with the processing capacity, calculate the expected amount of waste.

5.4.1.3.3 various types of waste possible environmental and health risks.

5.4.1.3.4 all types of waste treatment and disposal technology plan.

5.4.1.4 Emergency plan

5.4.1.4.1 When incidents, microbiological control and emergency plans affect diffusion, including identification of diffusion in the affected area, Isolate the affected area, emergency monitoring and other procedures and related technical methods.

5.4.1.4.2 After the accident, by the clean-up and disposal plans for contaminated areas.

5.4.1.4.3 After the accident, damage repair technology solutions ecosystem.

5.4.2 Evaluation Related Products

Name 5.4.2.1 microbial agent products.

5.4.2.2 the manufacturer or the dealer name, address and other contact information.

5.4.2.3 microbial agents product formulations and specifications, and the exact conditions of use descriptions.

5.4.2.4 microbial agent products are expected in the field and object.

5.4.2.5 When a microorganism accidental release or misuse, the emergency measures to be taken and so on.

5.4.2.6 microbial agents and methods for product preservation process.

5.4.2.7 Estimation of microbial agents product yield.

5.4.2.8 microbial agent product packaging and transportation.

5.4.2.9 microbial agents use of the product label.

Usage 5.4.3 Product Evaluation License 5.4.3.1 microbial agents at home and abroad the products obtained as well as other materials Ming official license.

5.4.3.2 microbial agent in the number of products using domestic and international scale, as well as relevant biosafety information.

5.4.3.3 microbial agent products in the domestic use of units and mailing address.