NY/T 2882.8-2017 English PDF (NY/T2882.8-2017)

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NY/T 2882.8-2017: Guidance on environmental risk assessment for pesticide registration - Part 8: soil organisms
NY/T 2882.8-2017
AGRICULTURE INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 65.020
B 17
NY/T 2882.7-2017
Guidance on Environmental Risk Assessment for
Pesticide Registration – Part 8: Soil organisms
ISSUED ON: DECEMBER 22, 2017
IMPLEMENTED ON: JUNE 01, 2018
Issued by: Ministry of Agriculture of PRC
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 5
4 Basic Rules ... 6
5 Assessment Procedures and Methods ... 6
6 Risk Reduction Measures ... 12
Appendix A (Normative) Overall Process of Environmental Risk Assessment of
Pesticides to Soil Organisms ... 13
Appendix B (Informative) Input Parameters and Output Values of
PECsoil_SFO_China Model ... 15
Appendix C (Informative) Input Parameters and Output Values of PRAESS
Model ... 17
Appendix D (Informative) Relevant Information on the Risk and Effect
Assessment Test of the Pesticide to the Soil Organisms ... 20
Appendix E (Normative) Toxicity Data Endpoints, Uncertainty Factors, and
Corresponding PEC Selection for Effect Analysis ... 22
Bibliography ... 23
Guidance on Environmental Risk Assessment for
Pesticide Registration - Part 8: Soil organisms
1 Scope
This Part specifies the principles, procedures and methods for risk assessment of the
impacts of pesticides on soil organisms.
This Part is applicable to the risk assessment of the impact on soil organisms for the
pesticide registration of chemical pesticide and the biological source with clear
chemical structures of active ingredients.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 31270.1 Test Guidelines on Environmental Safety Assessment for Chemical
Pesticides - Part 1: Transformation in Soils
GB/T 31270.15 Test Guidelines on Environmental Safety Assessment for
Chemical Pesticides – Part 15: Earthworm Acute Toxicity Test
GB/T 31270.16 Test Guidelines on Environmental Safety Assessment for
Chemical Pesticides – Part 16: Soil Microorganism Toxicity Test
NY/T 2882.1 Guidance on Environmental Risk Assessment for Pesticide
Registration – Part 1: General Principles
NY/T 2882.6-2016 Guidance on Environmental Risk Assessment for Pesticide
Registration – Part 6: Ground Water
NY/T 3091 Chemical Pesticide – Guideline for Earthworm Reproduction Test
NY/T 3149 Chemical Pesticide - Guideline for Terrestrial Field
Dissipation/Degradation
ISO 11268-3:2014 Effects of Pollutants on Earthworms – Part 3: Guidance on the
4 Basic Rules
The risk assessment of pesticides to soil organisms shall follow the following principles:
a) This Part is a risk assessment based on the protection of soil organisms. It
focuses on related soil organisms that are susceptible to pesticides. According
to the principles of sensitivity to pesticides, ecological value, and attention, it
attaches great importance on the ecological value and function of soils it
represents. In conjunction with management objectives, the purpose of risk
assessment is to ensure the survival and reproduction of important soil
organisms, soil ecological values and functions shall not be affected, or only
temporarily affected, so as to ensure the sustainability of soil resources in the
soil ecosystem.
b) The risk assessment of pesticides to soil organisms adopts a hierarchical
assessment method, and the risk is characterized by risk quotient (RQ).
5 Assessment Procedures and Methods
5.1 Overview
The risk assessment process of pesticides to soil organism environment is performed
in accordance with Figure A.1 of Appendix A.
5.2 Problem description
5.2.1 Risk estimation
Determine the possibility for exposure of soil organisms according to the pesticide use
methods. When soil organisms cannot be excluded from pesticide exposure according
to the method of use, a risk assessment shall be performed. When major metabolites
of pesticides are present, and toxicity data of major metabolites on soil organisms are
available, risk assessments shall be performed for major metabolites.
For pesticides used in multiple crops or multiple control objects, when the dosing
method, amount or frequency of dosing, and dosing time for each crop or control object
are different, then their use methods can be evaluated in groups:
a) When grouping, factors such as crop type, dosing amount, the number of dosing,
and dosing time shall be considered;
b) Determine the highest situation of soil biological risk according to the group and
carry out risk assessment for such group;
According to whether the half-life time of degradation (DT50) of the pesticide active
ingredient obtained at 20°C as per GB/T 31270.1 is greater than 180d to determine
whether the risk analysis of pesticide soil bioaccumulation exposure is triggered and
select the PEC for primary exposure analysis and advanced exposure analysis. When
the results of field dissipation studies are available, according to the soil half-life time
of degradation (DegT50) or half-life time of dissipation (DisT50) obtained as per NY/T
3149 or other applicable test principles is greater than 180d to determine whether to
trigger accumulative exposure risk analysis. When DT50 > 180d, the predicted soil
environmental accumulative concentration (PECaccu) obtained from the primary chronic
exposure analysis may be selected as the PEC, or the PECtwa obtained from the
advanced exposure analysis model may be used as the PEC.
5.3.2 Application of exposure analysis model
5.3.2.1 Selection of scene points
Select representative scene points according to the registered crops and control
objects that need to be evaluated for pesticides. Except that the data indicates that the
control objects are limited to certain specific scenes, all scene points with the crops
shall be selected. The dryland crop scene information adopted by PRAESS model and
China-PEARL model in this Part can refer to the software manual.
5.3.2.2 Model parameters
The input parameters and output values of the PRAESS model in this Part can refer to
Appendix C. The input parameters and input values of the China-PEARL model may
be implemented according to the provisions of Table E.1 in Appendix E of NY/T 2882.6-
2016.
5.3.2.3 Dosing method
According to the recommended use method of pesticide to be assessed (including
dosing method, dosing time, dosing frequency, dosing interval and dosing volume, etc.),
the maximum dosing volume, maximum dosing frequency, and minimum dosing
interval selected by the model are determined.
5.3.3 Primary exposure analysis
5.3.3.1 General methods for primary exposure analysis
For the primary exposure analysis of soil organisms, the predicted soil environmental
concentration (PEC) may be calculated according to the different models
recommended in this Part. In the model simulation analysis process, generally
conservative input parameters or model default parameters are selected to obtain the
primary PEC.
microorganisms) obtained from the toxic effect test by refining the exposure conditions
have multiple toxicity endpoint data, select the geometric mean of the effective toxicity
data. In the advanced effect assessment, if considering the protection of the soil
functions and soil or...