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HJ 837-2017 English PDF

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HJ 837-2017: Technical Guideline for Deriving Water Quality Criteria for the Protection of Human Health
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Basic data

Standard ID: HJ 837-2017 (HJ837-2017)
Description (Translated English): Technical Guideline for Deriving Water Quality Criteria for the Protection of Human Health
Sector / Industry: Environmental Protection Industry Standard
Word Count Estimation: 35,379
Date of Issue: 2017-06-09
Date of Implementation: 2017-09-01
Issuing agency(ies): Ministry of Ecology and Environment

HJ 837-2017: Technical Guideline for Deriving Water Quality Criteria for the Protection of Human Health


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Technical Guideline for Deriving Water Quality Criteria for the Protection of Human Health National Environmental Protection Standard of the People 's Republic of China Human health water quality benchmarking Technical guide Technical Guideline for Deriving Water Quality Criteria For the Protection of Human Health 2017-06-09 released 2017-09-01 implementation Ministry of Environmental Protection released I directory

Foreword

1 Scope of application

2 normative reference documents

3 Terms and definitions 2

4 Water quality benchmarking procedures

5 Data collection and evaluation .4

6 Determination of local parameters

7 benchmark derivation

8 benchmark review

9 benchmark application

Appendix A (normative) Criteria for assessing the quality of toxic data Appendix B (normative) Biology Individual Baseline Bioaccumulation Coefficient Derivation Method Appendix C (normative appendix) Uncertainty coefficient and selection of correction factors 23 Appendix D (informative) exposure decision tree method Appendix E (Informative Annex) Outline for the preparation of technical reports on human health water quality benchmarking. Appendix F (informative) Abbreviations 29

Foreword

For the implementation of the "People's Republic of China Environmental Protection Law" "People's Republic of China Water Pollution Control Law", scientific and standardized The development of human health water quality benchmarks, the development of this standard. This standard specifies the procedures, methods and technical requirements for the development of human health water quality benchmarks. Appendix A, Appendix B and Appendix C of this standard are normative and Appendix D, Appendix E and Appendix F are informative. record. This standard is the first release. This standard is a guiding standard. This standard is organized by the Ministry of Environmental Protection Science and Technology Standards Division. The drafting of this standard. China Environmental Science Research Institute (State Key Laboratory of Environmental Benchmark and Risk Assessment), China Institute of Eco-Environmental Sciences, Institute of Environmental Protection, South China Environmental Science Research Institute, China Center for Disease Control and Prevention, Central China University of Science and Technology. This standard is approved by the Ministry of Environmental Protection on June 9,.2017. This standard has been implemented since September 1,.2017. This standard is explained by the Ministry of Environmental Protection. Guidance on the development of human health water quality benchmarking

1 Scope of application

This standard specifies the procedures, methods and technical requirements for the development of human health water quality standards. This standard applies to China's surface water and aquatic products can provide freshwater waters in the long-term chronic health effects of pollutants Healthy water quality benchmarking. This standard does not apply to the development of human water standards for recreational water use. This standard does not apply to the development of microbiological and physical factors for human health water quality benchmarks.

2 normative reference documents

The contents of this standard refer to the following documents or their terms. For undated references, the valid version is applicable In this standard. Test method for acute inhalation toxicity of chemicals GB/T 605 Test method for acute percutaneous toxicity of chemicals GB/T 606 GB/T 778 Chemicals - Non - rodent sub - chronic (90 - day) oral toxicity test method Test method for two - generation reproductive toxicity of GB/T 7588 chemicals GB/T 21752 Chemical rodent 28 days Repetitive dose Oral toxicity test method Chemicals - Acute oral toxicity test - Acute toxicity classification ISO /TS 21757 GB/T 21759 National Standard for Chronic Toxicity Tests for Chemicals Test method for subchronic oral toxicity of rodents in chemicals GB/T Test method for screening reproductive toxicity of chemicals Chemicals - Test method for neurotoxicity of rodents GB/T 21793 Chemical in vitro Mammalian cell gene mutation test method GB/T 21800 Chemicals Biologically enriched waterfowl test Biologically enriched semi - static fish for chemicals GB/T 23 Terms and Definitions The following terms and definitions apply to this standard. 3.1 water quality criteria Is the abbreviation of water environmental quality benchmark, refers to the water environment of pollutants or harmful factors on human health, water ecosystem The maximum dose or level of use that does not produce a deleterious effect. 3.2 human health water quality standards for the protection of human health Only consider the drinking water and/or edible aquatic products exposure pathways, in order to protect human health for the purpose of water quality standards. 3.3 Reference dose, RfD The daily exposure dose of contaminants that do not produce deleterious effects to the population at lifetime exposure is for non-carcinogenic water An important parameter for derivation. 3.4 starting point point of departure, POD The Starting Point of Low Dose Extrapolation on the Dose - Effect Relationship of Carcinogenic Substance. 3.5 specific risk dose-specific dose, RSD Dose of contaminants corresponding to a particular risk level. 3.6 correlation source contribution rate relative source contribution, RSC Exposure through drinking water and edible aquatic products and its proportion to total exposure. 3.7 Bioconcentration factor bioconcentration factor, BCF The concentration of pollutants accumulated in the body due to exposure (without feeding) and the concentration of the contaminant in the water body To the equilibrium ratio, the unit L/kg. 3.8 bioaccumulation factor, BAF The concentration of contaminants accumulated in the body due to exposure (including ingestion) and the concentration of the contaminant in the water Balance ratio, unit L/kg. Baseline bioaccumulation factor Referred to as the baseline BAF, the concentration of pollutants in the water in the free dissolved state and its biological tissue in the standardization of lipid concentration Degree ratio, unit L/kg. 3.10 final nutrient level bioaccumulation factor final BAF for trophic level n (BAFTL n) Pollutants A BAF in a trophic level (usually 2, 3 and 4).

4 Water quality benchmarking procedures

The water quality benchmarking process consists of four steps (see Figure 1), as follows. (1) data collection and evaluation; (2) the determination of local parameters; (3) the derivation of the benchmark; (4) review of water quality benchmarks. Figure 1 Human health water quality benchmarking flow chart Data screening and evaluation Whether to meet the evaluation criteria Supplementary experimental data The parameters are determined (Exposure parameters, BAF, non-carcinogenic and carcinogenic parameters, RSC, etc.) Benchmarking (consumption of aquatic products; drinking water and consumption of aquatic products) Baseline values for review Dose - effect data Bioaccumulation data Water eco - environmental data Exposure parameters Pollutants Physical and chemical properties Non-carcinogenic data collection Pollutant properties Data collection and evaluation 5.1 Data types and sources The data mainly include dose-response data, exposure parameter data, bioaccumulative data, water eco-environmental data, pollution Physical and chemical properties of the data and environmental pollution data. Data sources are mainly Chinese/local measurement and survey data, domestic and foreign related databases, published literature/report. 5.2 Data collection 5.2.1 Dose-effect data (1) Contaminant toxicity data (animal and human) The toxicological data to be collected include acute, subacute, chronic toxicity, reproductive toxicity, developmental toxicity, neurotoxicity Sex, immunotoxicity, cardiovascular toxicity, and genotoxicity. (2) metabolic data of pollutants The metabolic data needed to be collected include. absorption (oral and other absorption pathways), distribution, metabolism, excretion, Biological monitoring, pharmacokinetic data, and so on. (3) population epidemiological data 5.2.2 Exposure parameter data (1) body weight, water intake and aquatic product intake; (2) Contaminant-related exposure and exposure routes (including drinking water/consumption of aquatic products, dietary intake, sediment/soil Soil, air and special use, etc.) data. 5.2.3 Bioaccumulation data The data needed for bioaccumulation to be collected include BCF and BAF data, in vivo/in vitro metabolic data, Residual data in organisms, content in water and distribution data, physical and chemical properties of pollutants (eg, Kow, ionization Constant, pH, etc.), biomagnification coefficient data, and bio-lipid content data. 5.2.4 Other data Other data to be collected include. physical and chemical constants (eg, pH, dissolved organic carbon concentration, DOC Granular organic carbon concentration POC), biological species and distribution data, trophic level survey data. 55.3 Data Screening and Evaluation 5.3.1 Screening principles (1) the preference of the country/region of the local data, in the absence of local data, can use foreign authority Published data; (2) the preferred use of international and national standards test methods and industry technical standards, the operating process to follow the good Laboratory data (Good Laboratory Practice, GLP) experimental data (see GB/T 605, GB/T 606, GB/T 778, GB/T 7575, GB/T 21752, GB/T 21757, GB/T 21759, GB/T 21763, GB/T 21766, GB/T 21787, GB/T 21793, GB/T 21800 and GB/T 21858); (3) for non-standard test method of experimental data, in the assessment of its experimental methods, the results can be used after scientific and reasonable; (4) preferentially the toxicity data of the end point of the sensitive toxicity effect; (5) the use of human toxicity data, the lack of adequate human toxicity data can be used animal toxicity data; (6) in the selection of human toxicity data, the preferred use of environmental epidemiological data, if the lack of adequate data available Epidemiological data. 5.3.2 Screening methods and quality evaluation (1) the data generation process is not fully consistent with the experimental criteria, but there is sufficient evidence to prove that the data can be used scientifically; (2) the same indicator of the same indicators of experimental data difference of more than 10 times, should be removed outliers; (3) there is a conflict or contradiction between the data generation process and the experimental criteria, and there is insufficient evidence that the data is available and the experiment The process can not be convincing or judged that the data that the expert can not accept is not available; (4) does not provide sufficient experimental details, can not determine the data reliability data is not available; (5) the minimum amount of toxic data required to establish a dose-response curve; (6) Criteria for assessing the quality of toxic data are given in Appendix A.

6 Determination of local parameters

6.1 Exposure parameters Priority is given to the use of local exposure parameters obtained by standard survey methods, and in the absence of actual exposure parameters, Data released by country or place. This standard recommends the use of adult (18 years and above) exposure parameters are as follows. (1) the average weight. 60.6 kg; 6 (2) Daily water intake. 1.85 L/d; (3) daily intake of aquatic products. 0.0237 kg/d. 6.2 Bioaccumulation coefficient BAF BAF is divided into individual biological baseline BAF, species baseline BAF, trophic level baseline BAF and final trophic grade BAF. Pollutants can be divided into non-ionic organic compounds, ionic organic compounds, inorganic compounds and organometallic compounds , Respectively, choose a different derivation program (see Figure 2). According to the hydrophobic, metabolic rate and biomagnification of contaminants And so on to select specific individual biological baseline BAF derivation method. 6.2.1 Individual biological baseline BAF derivation method Depending on the hydrophobicity, metabolic rate and biomagnification of contaminants, select the appropriate one in steps 1-6 shown in Figure 2 Of the derivation of the procedure, the individual biological baseline BAF in the program 1-6 has a total of four methods, the method before the marked number that the The priority of the method is used. The priority order is field test method, biological phase-sediment accumulation coefficient method (ie BSAF Method), laboratory bioaccumulation coefficient × food chain multiplication method (ie, laboratory BCF × FCM method) and octanol - water distribution Coefficient × food chain multiplier method (ie Kow × FCM method), the specific method see Appendix B. 6.2.2 Species Baseline BAF Derivation Method The geometric mean of a number of individual biological baselines BAF is "the baseline BAF of the species". In the calculation process, should Carefully review the rationality of individual biological baseline BAF data and its sources. Need to contaminate substances in water and biological tissues Content Spatiotemporal distribution characteristics Get as much measurement data as possible to ensure data reliability; should remove significant data Different than 10 times the data is abnormal data). 6.2.3 Nutritional Baseline BAF Derivation Method The geometric mean of BAF for multiple species in a trophic level is the "trophic level baseline BAF". Should be calculated second, 3 and 4 Nutritional Grade Baseline BAF. When more than one trophic level baseline BAF is obtained, the prioritization of the different derivation methods and the uncertainty of the results should be considered Sex, select the optimal nutrition level baseline BAF. 6.2.4 Final Nutritional Level BAF Derivation Method The final trophic level BAF is used to describe the bioaccumulation potential of contaminants in specific trophic levels (grades 2, 3 and 4) force. The final trophic level BAF for each trophic level is calculated by equation (1). The final trophic level [() () 1) l TLn fdTLnTLnBAF BAF ff     Nutritional grade Baseline (1) Where. The final trophic level of BAFTL n-contaminants in a trophic level (grades 2, 3 and 4) of BAF, L/kg; 7 Nutritional level Baseline BAFTL n - Average baseline of contaminants at a trophic level (grades 2, 3 and 4) BAF, L/kg; (Fl) TL n - lipid fraction of% of the aquatic organisms consumed in a trophic level,% of the calculation method see Appendix B; Ffd - the free dissolved fraction of contaminants in water,%, see Appendix B for calculation. Figure 2 bioaccumulation factor derivation procedure Collect and audit data Classification of contaminants Nonionic Organic Compounds Ionic Organic Compounds Inorganic Compounds and Organometallic Compounds Is ionization negligible? Hydrophobic Medium to high hydrophobic Sex (lgKow≥4) Low hydrophobicity (LgKow < 4) Procedure 1 1. Field test method 2. BSAF method 3. Laboratory BCF × FCM method 4. Kow × FCM method Procedure 2 1. Field test method 2. BSAF method 3. Laboratory BCF Procedure 3 1. Field test method Or laboratory BCF 2. Kow method Procedure 5 1. Field measurements Law or laboratory BCF method Program 4 1. Field measurements Law or laboratory BCF method whether Metabolism? no Yes Biological amplification Metabolism? Low high and low Procedure 6 1. Field measurements 2. laboratory BCF × FCM method Species Baseline BAF Nutritional grade baseline BAF Final Nutrition Level BAF Individual biological baseline BAF 86.3 non-carcinogenic effects of toxicity parameters This standard uses the reference dose (RfD) as a non-carcinogenic toxicity parameter for non-carcinogenic water quality Derivation. 6.3.1 Data requirements The animal toxicity data required to obtain the reference dose (RfD) should also include. (1) two mammals and one of them must be chronic toxicity test data for rodents; (2) a mammalian multi-generation reproductive toxicity test data; (3) Developmental toxicity test data of two mammals under the same conditions of administration. Contaminants with immunotoxicity and neurotoxicity should be considered for their specific toxicity. 6.3.2 Calculation method The reference dose (RfD) calculation method includes the reference dose method (BMD) and the NOAEL/LOAEL method, Using a standard dose method. (1) Reference dose method (BMD) In the first step, on the basis of 6.3.1 data, the explicit effect and its dose - effect relationship; The second step, analysis of dose-effect relationship, caused by 10% effect of the corresponding dose is the BMD value, BMD 95% The lower limit of confidence interval is BMDL value; The third step, select the smallest BMD and BMDL values; The fourth step is to analyze the uncertainty coefficient (UF) according to the experimental conditions and the data quality. In the fifth step, calculate RfD according to formula (2). BMDL RfD = UF (2) Where. RfD - reference dose, mg/(kg · d); BMU-BMD 95% confidence interval lower limit, mg/(kg · d); UF - Uncertainty coefficient, dimensionless. See Appendix C. for values. (2) NOAEL/LOAEL method Calculate the reference dose according to formula (3). Or   NOAEL LOAEL RfD = UF MF UF MF (3) Where. NOAEL - invisible adverse effect concentration, mg/(kg · d); 9LOAEL - the lowest visible harmful effect concentration, mg/(kg · d); MF-correction factor, dimensionless. See Appendix C. for values. In the formula (3), the parameters of RfD and UF are given in Equation (2). If there is no reasonable invisible concentration of harmful effects (NOAEL), the lowest visible harmful effects (LOAEL) values to estimate the reference dose. 6.4 carcinogenic toxicity parameters The carcinogenic toxicity parameters include starting point (POD) and specific risk dose (RSD), where the starting point is used for carcinogenicity In the non-linear mode of reference, the specific risk dose is used to derive the baseline derivation in the carcinogenic linear mode of action. 6.4.1 Starting point POD The calculation method of the carcinogenic effect starting point (POD) includes the reference dose method (BMD) and the NOAEL/LOAEL method, Priority is given to the baseline dose method. (1) Determination of the starting point of the reference dose method (BMD) When the dose-response curve of carcinogenic contaminants is available, the starting point can be determined by the BMD method, ie POD = BMDL. See 6.3.2 for the acquisition of BMDL. (2) NOAEL/LOAEL method When the POD can not be obtained by BMD method, the invisible harmful effect concentration (NOAEL) can be used as the starting point, If there is no reasonable NOAEL value, the lowest visible harmful concentration (LOAEL) value can be used as the starting point. in case Without a reasonable NOAEL/LOAEL value, you can use the LED10 value (10% of the carcinogenic effect of the corresponding dose of 95% confidence Interval lower limit) to determine the starting point. (3) when the animal experimental data based on the starting point, through the interspecies dose adjustment or toxic metabolic kinetic data Into a human equivalent dose. Body equivalent dose calculation formula. Ani......
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