China implements a periodic reevaluation of all existing active ingredients every 15 years as standard practice. During the reevaluation the following are assessed: technical assessment, joint experimentation, and data use authorization.
On 16 Apr 2018，Shandong ICA (Institute for the Control of Agrochemical, the provincial unit of ICAMA) opened a 45-day investigation on butachlor production and usage nationwide. In 2016, MoA initiated the revaluation on butachlor and 7 other active ingredients and an internal probe was opened to assess the provincial department. The national survey was organized by Shandong ICA under the delegation from the MoA/MoARR. Domestic butachlor producers are required to fill and submit 3 questionnaires by 31 May 2018 on following data:
- Annual output, domestic sales and destination province, export and export destination in recent 2 years;
- Type of pesticide risk (crop damage, pest resistance, residue, human and animal poisoning, environmental pollution), frequency, incidents, reason and treatment;
- Availability of data on environmental impact on surface and underground water, data source (proprietary or referred data), general conclusion on risk to water body and proposed mitigation measure
During the most recent pesticide regulatory reform, China standardized the administrative and technical procedures of pesticide reevaluation. A reevaluation of existing active ingredient will be initiated under any of the following 2 conditions:
- Periodic reevaluation: the pesticide was registered/reevaluated for over 15 years;
- Special-reevaluation: Pesticide active ingredient, impurity, metabolite and degradation product causes native impacts on food safety, human and animal health or environment;
MoARR will compile and release a list of candidates for reevaluation and the associated work plan. All affected stakeholders (registrants) will receive a written notice to participate in the internal briefing (pre-notice) on the background and reason for the reevaluation, as well as being informed on data requirements and submission deadline. MoARR may decide whether or not to continue the reevaluation after examining the data/feedback.
If the reevaluation proceeds, a formal notice of reevaluation will be circulated to all affected registrants, who will decide whether to participate in the reevaluation and make a formal statement on bearing or waiving the rights and responsibilities corresponding to the reevaluation. MoA may alter or cancel the registrations if no registrant wants to participate in the reevaluation and issue a notice of terminating pesticide reevaluation.
If the registrants want to participate in the reevaluation, the reevaluation will proceed to technical review. Joint experimentation by different registrants or data use authorization are encouraged to minimize repeat testing at this stage. Furthermore, if the experimentation has not yet been established with official testing method/guidance, registrants and testing facilities are allowed to communicate with authorities on acceptance of experimental design, performance of study, etc.
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