T/SHSOT 001-2021 Active Group standards

T/SHSOT 001-2021 Animal Drug Environmental Risk Assessment Guidelines

Publish Date: 2021-04-20 Implement Date: 2021-05-10 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SHSOT 001-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Environmental protection

ICS Name: Integrated Environment and Environmental Protection

Publish Date: 2021-04-20

Implement Date: 2021-05-10

Scope

Scope: This guideline establishes the procedures, content, and methods for the environmental risk assessment of veterinary chemical drugs (hereinafter referred to as "veterinary drugs"), as well as the content that should be covered in the report on the environmental risk assessment of veterinary drugs. This guideline applies to the environmental risk assessment of veterinary drugs, but not to the environmental risk assessment of veterinary biological products or human medicines. Main technical content: 5.1 Pre-assessment of the environmental risk of veterinary drugs 5.2 First stage: Environmental exposure assessment of veterinary drugs 5.2.1 Emission situation of veterinary drugs 5.2.2 Calculation of the predicted environmental concentration of veterinary drugs 5.2.3 Triggering conditions of the second stage 5.3 Second stage: Ecotoxicity test and risk assessment of veterinary drugs 5.3.1 Second stage A-level ecotoxicity test and risk assessment 5.3.2 Second stage B-level ecotoxicity test and effect evaluation 5.4 Environmental risk assessment under three rearing models 5.4.1 Environmental risk assessment of centralized rearing models 5.4.2 Environmental risk assessment of pasture rearing models 5.4.3 Environmental risk assessment of aquaculture models 6 Report on the environmental risk assessment of veterinary drugs 6.1 Framework of the report on the environmental risk assessment of veterinary drugs 6.1.1 Categories of reports on the environmental risk assessment of veterinary drugs 6.1.2 Framework of reports on the environmental risk assessment of veterinary drugs that do not require evaluation 6.1.3 Framework of reports on the environmental risk assessment of veterinary drugs that do not require ecotoxicological data 6.1.4 Framework of comprehensive reports on the environmental risk assessment of veterinary drugs 6.2 Compilation requirements 6.2.1 Calculation of predicted environmental concentration 6.2.2 Ecotoxicity test 6.2.3 Evaluation conclusions Appendix A (