The Pesticide Management Division of the Ministry of Agriculture and Rural Affairs has issued a letter soliciting comments on the “Regulations on the Management of Pesticide Risk Monitoring and Evaluation.”

On April 9, 2020, the Pesticide Management Division of the Ministry of Agriculture and Rural Affairs issued a letter soliciting comments on the “Regulations on the Management of Pesticide Risk Monitoring and Evaluation (Draft for Public Comment).” The full text is as follows:

To standardize pesticide risk monitoring and evaluation, ensure the safety and efficacy of registered pesticides, safeguard the quality and safety of agricultural products and the health of humans and livestock, and protect agricultural production and the ecological environment, in accordance with the provisions of the Regulations on the Administration of Pesticides, our agency has drafted the “Measures for the Management of Re‑evaluation of Pesticide Risk Monitoring (Draft for Comments).” This document is hereby circulated for your comments. Please review it carefully and submit your formal written feedback to our agency by April 17, 2020, along with an electronic copy.

Contact: Pesticide Management Division, Pesticide Management Department, Ministry of Agriculture and Rural Affairs; telephone: 010-59192899; email: pmd@agri.gov.cn; mailing address: Pesticide Management Division, Ministry of Agriculture and Rural Affairs, No. 11, Nongguan Zhan Nanli, Chaoyang District, Beijing.

Re‑evaluation and Registration Division, Pesticide Testing Institute, Ministry of Agriculture and Rural Affairs: Zong Fulin; telephone: 010-59194091; email: red@agri.gov.cn.
 

Chapter I General Provisions

Article 1: In order to standardize the monitoring and evaluation of pesticide risks, ensure the safety and efficacy of registered pesticides, safeguard the quality and safety of agricultural products and the safety of humans and livestock, and protect agricultural production and the ecological environment, these Provisions are hereby formulated in accordance with the Regulations on the Administration of Pesticides.

Article 2. Pesticide risk monitoring refers to the surveillance of safety risks associated with pesticide use in areas such as agricultural production, human and animal health, the quality and safety of agricultural products, and ecological environmental safety, as well as the tracking of dynamic changes and development trends in these risks.

The pesticide evaluation referred to in these Regulations means the process of conducting a re‑evaluation of pesticide products that are currently validly registered (hereinafter referred to as “pesticide re‑evaluation”) and, based on the evaluation results, implementing appropriate regulatory measures.

Article 3 Pesticides registered and used within the territory of the People’s Republic of China shall undergo pesticide risk monitoring and assessment.

Article 4 The Ministry of Agriculture and Rural Affairs and the provincial agricultural and rural affairs departments are responsible for organizing and conducting pesticide risk monitoring and assessment.

The pesticide registration and testing agencies and plant protection institutions under the Ministry of Agriculture and Rural Affairs and provincial-level agricultural and rural affairs departments are responsible for the specific implementation of pesticide risk monitoring.

The pesticide registration and testing agencies under the Ministry of Agriculture and Rural Affairs are responsible for the specific tasks of pesticide re‑evaluation, while the provincial pesticide registration and testing agencies provide assistance in carrying out these tasks.

Article 5 The holder of a pesticide registration certificate shall, in accordance with the requirements, submit production and sales data as well as information on use-related risks to the agricultural and rural affairs authorities at or above the county level.

Article 6: Units and individuals are encouraged to promptly report to the agricultural and rural affairs authorities at or above the county level information on the safety and efficacy of registered pesticides, as well as any potential risks, and to submit recommendations for management measures.

Chapter 2: Risk Monitoring

Article 7: Agricultural and rural departments at or above the provincial level shall establish a pesticide safety risk monitoring system and regularly conduct monitoring and surveys to assess the safety risks associated with pesticide use in areas such as agricultural production, human and animal health, the quality and safety of agricultural products, and ecological environmental protection.

(1) In the area of agricultural production safety, conduct surveys and monitoring to assess crop damage caused by pesticide use—both in the current and subsequent cropping seasons—as well as the emergence of resistance in target pests and pathogens. Priority should be given to monitoring pesticide products that are prone to causing phytotoxicity under normal conditions of use or fail to achieve the intended control efficacy at the approved application rates.
(2) With regard to human and animal health and safety, the survey and monitoring shall assess adverse reactions associated with pesticide use among applicators, handlers, and other exposed individuals, with particular emphasis on pesticides that pose serious risks to humans, livestock, and poultry.
(3) With regard to the quality and safety of agricultural products, the survey will assess instances of pesticide residues exceeding regulatory limits in agricultural commodities, with a particular focus on identifying the specific pesticide products responsible for such violations in vegetables, fruits, tea, mushrooms, Chinese medicinal herbs, and other agricultural products.
(4) In terms of ecological and environmental safety, the survey and monitoring shall assess the impacts of pesticide use on non-target organisms as well as on groundwater, surface water, and soil. Particular attention shall be given to pesticides that pose significant risks to bees, birds, silkworms, aquatic organisms, natural enemies, and groundwater.
(5) Other circumstances. Cases in which the Ministry of Agriculture and Rural Affairs deems it necessary to conduct investigations and monitoring.

Article 8: A monitoring and information reporting system shall be established. Provincial agricultural and rural affairs authorities shall promptly report pesticide safety risk incidents to the Ministry of Agriculture and Rural Affairs and, by year’s end, submit an annual report on the overall status of pesticide use with respect to safety and efficacy.

Chapter 3 Reevaluation

Article 9. Pesticide re-evaluation comprises two categories: periodic evaluation and special‑purpose evaluation.

Periodic evaluation refers to the systematic, regular assessment of the safety, efficacy, and economic viability of registered pesticides in response to changes in pesticide regulatory policies, risk‑assessment methodologies, and evaluation criteria.

Special‑case evaluation refers to the timely assessment, based on risk monitoring, literature data, and other relevant information, of pesticides that may cause or have already caused serious harm, pose significant risks, or fail to comply with current national pesticide management policies.

Article 10: For pesticide varieties that have been registered for more than fifteen years, the Ministry of Agriculture and Rural Affairs shall, based on the production and use of pesticides as well as their safety risk profile, formulate a list for periodic evaluation and organize such evaluations in phases and batches.

Article 11: When the use of a particular pesticide results in any of the following circumstances, a special assessment shall be initiated:

(1) Impact on agricultural production safety. When used in accordance with the registered application instructions, if a single incident results in phytotoxicity affecting more than 10,000 mu of crops or causing economic losses exceeding RMB 10 million; or if, over two consecutive years, phytotoxicity occurs in three or more distinct regions, with cumulative affected areas exceeding 10,000 mu or cumulative economic losses surpassing RMB 10 million; or if the target pest/pathogen develops severe resistance, leading to control efficacy below 50% even when applied at the highest registered dosage.
(2) Threatening human and animal health and safety. In agricultural production or daily life, if poisoning affects 50 or more people, or if 1,000 or more livestock are poisoned, or if the harm to human and animal health is irreversible and severe, or if the harm is difficult to effectively control.
(3) Endangering the quality and safety of agricultural products. This includes cases where the dietary risk assessment exceeds 100%, or where pesticide residue levels exceed regulatory limits, resulting in poisoning affecting 50 or more individuals.
(4) Undermining ecological and environmental safety. Where the use of pesticides results in economic losses exceeding RMB 10 million to honeybees, birds, aquaculture, or other sectors, or where it causes serious adverse impacts on the ecological environment, including groundwater, surface water, and soil.
(5) Where the Ministry of Agriculture and Rural Affairs deems it necessary to conduct a special evaluation.

Article 12. In accordance with the conditions for initiating the re‑evaluation of registered pesticides, the pesticide registration agency under the Ministry of Agriculture and Rural Affairs shall prepare a list of candidate products for evaluation and draft an implementation plan for the re‑evaluation. The implementation plan shall specify the objectives and legal basis for initiating the re‑evaluation, the list of technical documents to be submitted, the time limit and procedures for acceptance, as well as the methods for addressing any related issues.

The Ministry of Agriculture and Rural Affairs convened the National Pesticide Registration Review Committee to review the draft implementation plan for the re-evaluation of pesticides.

The pesticide registration agency of the Ministry of Agriculture and Rural Affairs has organized a public consultation, revised the draft to develop an implementation plan for the re‑evaluation of pesticides, and submitted it to the Ministry for approval and promulgation.

Article 13: Following the promulgation and implementation of the Pesticide Re‑evaluation Implementation Plan, applications for new registrations of pesticide varieties subject to re‑evaluation shall submit technical documentation in accordance with the “Requirements for Pesticide Registration Data” and the provisions of the Pesticide Re‑evaluation Implementation Plan.

Article 14: The holder of a pesticide registration certificate shall collect and submit the required documentation in accordance with the implementation plan for the re‑evaluation of pesticides. If additional registration trials are necessary, such trials shall be conducted at registration trial facilities accredited by the Ministry of Agriculture and Rural Affairs. Holders of pesticide registration certificates containing the same active ingredient may jointly conduct trials and share the resulting data.

Article 15: The holder of the registration certificate shall submit the relevant materials within the prescribed time limit. Failure to do so by the deadline shall be deemed as a refusal to participate in the relevant pesticide re‑evaluation process.

For registrants who have participated in the completion of the relevant periodic review of pesticides, the corresponding test reports required for supplementary registration renewal shall be deemed to have been submitted.

Article 16: Upon completion of the re‑evaluation of a pesticide, the pesticide registration agency under the Ministry of Agriculture and Rural Affairs shall prepare a re‑evaluation report for the relevant pesticide variety and solicit comments from the registrant.

Article 17 The pesticide registration and testing agency of the Ministry of Agriculture and Rural Affairs shall submit the pesticide re‑evaluation report to the National Pesticide Registration Review Committee for review.

Chapter 4: Management Measures

Article 18: The National Pesticide Registration Review Committee shall, on the basis of the pesticide re‑evaluation report, review the safety, efficacy, and economic viability of the relevant varieties and products, and submit its opinions and recommendations.

Article 19: The Ministry of Agriculture and Rural Affairs, based on the review results of the National Pesticide Registration Review Committee, shall approve the continued registration of varieties and products that comply with current administrative policies and technical requirements. If it is found that a pesticide poses serious harm or significant risks to agricultural production, human and animal safety, the quality and safety of agricultural products, or the ecological environment, the Ministry shall revoke or amend the corresponding pesticide registration certificate, or impose restrictions or prohibitions on its use.

Article 20: If the holder of a registration certificate fails to submit, or fails to submit in accordance with the requirements of the pesticide re‑evaluation implementation plan, the technical data necessary for risk assessment, resulting in the inability to evaluate the associated risks, the relevant registration certificate shall be revoked or amended.

Article 21: For pesticides that have undergone re-evaluation, the registrant shall submit supplementary documentation demonstrating compliance with the re-evaluation requirements when applying for renewal of the registration.

Chapter 5: Other Matters

Article 22. These Provisions shall be interpreted by the Ministry of Agriculture and Rural Affairs.

Article 23: These Provisions shall come into force as of X month X, 2020.

Source: Pesticide Management Division, Ministry of Agriculture and Rural Affairs