China will strengthen pesticide post-registration management and implement transparent procedures and criteria.
On April 8th, 2020, China MoARA released a new draft regulation, explaining the target, mechanism, post-registration obligation, and criteria for a periodic and special re-evaluation of registered pesticides.
The ministerial regulation details the process for authorities to investigate, track, and assess the risks to agricultural production, human and animal health, food safety and the ecosystem caused by the uses of a registered pesticide:
- Agricultural production-Damage to present crop and succeeding crop, development of pest resistance (Pesticide apt to course crop damage and fails to reach the anticipated control effect under at authorized dose will be prioritized);
- Human and animal health-Adverse effect on handlers, applicators, bystanders, and livestock.
- Agricultural product quality safety-MRL related cases (pesticides have the most violations related to vegetables, fruits, tea, edible fungi, and medicinal herbs will be prioritized);
- Ecological environment-Impacts on non-target organisms, groundwater, surface water, and soil ecosystem. (Pesticides cause greater risks to bee, avian, silkworm, aquatic organisms and natural enemies will be prioritized).
Pesticides registered for more 15 years will be periodically reevaluated in batches, but the special review could be initiated at any time under the following conditions:
- Pesticide caused one-off crop damage of more than 666.7 hectares or 10 million Yuan, or total crop damage of more than 666.7 hectares or 10 million Yuan at three different sites in 2 consecutive years, or pesticide whose control effect is less than 50% on its highest registered dose；
- The pesticide has poisoned over 50 people or 1000 livestock or caused irreversible damage to people or livestock;
- Pesticide obtained a risk quotient of over 100% after dietary risk assessment or caused over 50 food poisoning incidents;
- Pesticide resulted in 10 million Yuan of economic losses to bee, bird, and aquaculture farming industries or caused a serious impact on groundwater, surface water, and soil ecosystem.
The agrochemical control organization under the MoARA will draft a list of pesticides subject to the reevaluation and implementation plan based on criteria mentioned above. This list specifies the aim, reason, list of data to be supplemented, deadline for data submission and other relevant matters. After the deliberation by the National Expert Committee of Pesticide Registration and public consultation, MoARA will announce and conduct the final implementation plan accordingly. New applications of these pesticides need to submit scientific data following the data requirements and the implementation plan.
At the routine monitoring stage, the existing registrants should submit information such as production, sales, and usage of their products upon the request by the agricultural authorities above the county level. Once a reevaluation was initiated, the registrants need to submit the supplemental data and conduct necessary tests. The test should be completed at MoARA-accredited labs and can be co-sponsored by multiple registrants that have registered the same active ingredient. After the collection of these data, a reevaluation report will be drafted and deliberated during the meeting of the Expert Committee, and MoARA would continue, cancel, and amend existing registration or issue necessary injunction/restriction. If MoARA cannot complete the reevaluation due to a failure in the collection of supplemental data from these registrants, the registration would be canceled or amended. If the pesticide passes the revaluation, the registrants need to submit the supplemental data during the renewal. Registrants who summited data during the reevaluation stage are deemed to have supplemented the data required for registration renewal.
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