Liu Xue: A Preliminary Analysis of Post-Registration Reevaluation of Pesticides

　   Pesticide As an essential agricultural input, its safety and efficacy have long been key concerns. Particularly now that food production has largely achieved self-sufficiency, the public has raised higher standards for agricultural production safety, the quality and safety of agricultural products, ecological and environmental safety, and the health and safety of both humans and livestock. In 2017, the… Pesticide The revision of the Administrative Regulations and the promulgation of accompanying rules have introduced an important change: for the first time, it stipulates “for those registered for more than 15 years”... Pesticide Varieties are subject to periodic evaluations organized by the Ministry of Agriculture and Rural Affairs, based on changes in production practices and industrial policies. With respect to the more than 680 active ingredients and nearly 40,000 compounds accumulated over the past four decades, Pesticide Products should be appropriately regulated, whether in terms of product quantity, formulation optimization, or methods of use and application scope. Pesticide “Slimming down” means “subtraction”—this is… Pesticide Management is an objective necessity for adapting to the new circumstances, and it also builds upon the groundwork laid by earlier research and exploration. Pesticide The concrete practices and comprehensive promotion of post-registration evaluation. Based on recent work experience, the author examines… Pesticide Understanding of the registration re-evaluation process in China Pesticide This paper reflects on the current status, challenges, and corresponding countermeasures of registration-based re-evaluation work.
　　1   Pesticide Re-evaluation after registration is a globally accepted practice.
　　China was established in 1963. Pesticide The Testing Institute was reestablished in 1978, and to this day it has been in operation for approximately 40 years. Pesticide Compared with developed countries and regions such as the United States and the European Union, registration management has consistently remained at a stage of following and learning. Pesticide Post‑registration evaluation is subject to clear regulatory requirements in countries such as those in Europe and North America, and its implementation is currently underway.
　　1.1 United States
　　About Pesticide After registration, post‑registration evaluations have also undergone several changes in the United States. Under the Federal Insecticide, Fungicide, and Rodenticide Act of 1988, the U.S. Environmental Protection Agency (EPA) established procedures for post‑registration oversight… Pesticide Implementation Pesticide Re‑registration management. Accordingly, from 1988 to 2008, the U.S. Environmental Protection Agency (EPA) conducted reviews of 1,150 active ingredients under 613 categories; among these, 384 categories were approved, while 229 were withdrawn.
　　In 1996, the U.S. Environmental Protection Agency (USEPA) amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pursuant to the Food Quality Protection Act. Following this amendment, it was proposed that… Pesticide Registration re-evaluation. FIFRA requires that registered products be re-evaluated every 15 years. Pesticide Conduct a re-evaluation and reassess in accordance with the current registration policies and standards to ensure that the registration has been duly completed. Pesticide When used in accordance with the label, it does not pose an unacceptable risk to the environment or to human and animal health. Since 2006, a first round of periodic re-evaluations has been conducted for 1,166 active ingredients across 745 product categories, with completion scheduled by October 2022; this work is currently underway.
　　To ensure Pesticide After registration, the work is evaluated; in the United States, this applies only to Part 3 of FIFRA. Pesticide It was raised during registration. Pesticide The general principles, evaluation procedures, time limits, data requirements, and outcome‑handling provisions for registration re‑evaluation are further specified in Title 40 of the Code of Federal Regulations, specifically in Part 155 on environmental protection. Pesticide The relevant requirements for re-evaluation have been further specified.
　　1.2 The European Union
　　For Pesticide Following the registration process, the European Union has primarily relied on the 1991 Council Directive on the placing of plant protection products on the market and the 2009 Council Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, which replaces Council Directives 91/414/EEC and 79/117/EEC.
　　Under Directive 91/414/EEC, the re‑evaluation period is no more than ten years and, based on the level of safety, active substances are classified into six categories, corresponding to Annexes I through VI. Active substances that meet the safety requirements are listed in Category 1, i.e., Annex I; however, if any active substance included in Annex I is found to pose risks to human or animal health or to environmental safety, it will be removed from Annex I and subject to a re‑evaluation process. To implement Directive 91/414, in 1993 the European Union initiated nearly 1,000… Pesticide The re-evaluation of active ingredients, after nearly a decade of review, has been completed for 897 substances in Europe. Pesticide In the re-registration process, 215 active ingredients passed the evaluation, while 682 were withdrawn, accounting for 61% of the total number evaluated.
　　Regulation (EC) No 1107/2009, adopted on 21 October 2009, replaced Directive 91/414/EEC and entered into force on 14 June 2011. Under the new regulation, the period for periodic re-evaluation has been revised to a maximum of 15 years.
　　1.3 Canada
　　Canada Pesticide Management is primarily governed by the Pest Control Products Act, which was enacted in 1980, repealed in 1995, re‑enacted in 2002, and amended on June 28, 2006.
　　There is a dedicated section in the bill that describes… Pesticide Re‑evaluation involves six chapters and 21 articles. Since 2016, three additional key related documents have been issued, namely the Work Plan for Re‑evaluation (2015–2020), Pesticide Reevaluation of management policies, cycles, and special reevaluations Pesticide Cancellation and amendment policy. Among them, Pesticide The Reevaluation Management Policy has replaced the reevaluation regulations issued in 2012.
　　Through re‑evaluation, Canada adopted a centralized approach for products registered before April 1, 1995, completing the re‑evaluation by April 1, 2005. This process resulted in the periodic re‑evaluation of 401 active ingredients, with more than 20% of these active ingredients being phased out.
　　It should be noted that, on the basis of periodic re-evaluations, the United States, Canada, and the European Union have all introduced the concept of “special re-evaluation,” which applies to substances that have already been registered for use. Pesticide For products, when potential serious safety concerns are identified that could affect humans or the environment, the government may initiate a special re‑evaluation at any time. The scope of such a special re‑evaluation includes reviewing existing data, requiring the submission of new information or research findings, assessing confirmed risks, and developing appropriate risk‑management measures. Unlike the re‑registration and periodic re‑evaluation procedures, this process typically applies only to specific products or categories that may pose risks.
　　In addition, countries such as Japan and Australia have also formulated their own… Pesticide Re-evaluation of policies is currently underway. Pesticide Post-registration management has been implemented, achieving… Pesticide Adjustment of the product mix, driving Pesticide The “metabolism” of the active ingredient.
　　2 Our country Pesticide After registration, management has carried out extensive and highly effective work.
　　By comparison, China Pesticide The policy of conducting evaluations after registration has also undergone a process of development and continuous improvement, evolving from nothing to something. In China, Pesticide Having been engaged in registration management for nearly 40 years, Pesticide The hallmark of the legalization of post-registration evaluation was the 2017… Pesticide Regulations and Pesticide The revised “Regulations on Registration Management” has been promulgated. The regulations explicitly stipulate provisions for cases where registration has exceeded 15 years. Pesticide Varieties undergo periodic evaluation, and at the same time, when it is found that they have been registered… Pesticide For substances that pose serious harm or significant risks to agriculture, forestry, human and animal health, the quality and safety of agricultural products, and the ecological environment, the Ministry of Agriculture and Rural Affairs shall organize a review; this is also consistent with the criteria for initiating “special re‑evaluation” as articulated by European and American countries.
　　Prior to 2017, the Ministry of Agriculture and Rural Affairs organized and carried out… Pesticide Post-registration management is primarily based on fiscal project support. Starting with the implementation of pyrethroid-based… Pesticide Effects on paddy fields, studies on the risks of carbofuran to groundwater and birds, the impact of fipronil on honeybees, and the risks associated with Bacillus thuringiensis, imidacloprid, avermectin, lambda‑cyhalothrin, and other substances. Pesticide specialized research and evaluation. Furthermore, from 2005 to 2009, a systematic program was carried out on highly toxic substances. Pesticide Research on the integration of alternative product technologies has been conducted, and since 2009, projects for the supervision of agricultural product quality and safety have been organized. With financial support, the Ministry of Agriculture and Rural Affairs has collected and compiled relevant data through specialized surveys, validation trials, and field monitoring, thereby promoting the phase-out of highly toxic and high-risk substances. Pesticide From 1992 to 2017, a total of 43 substances, including hexachlorocyclohexane, DDT, and methamidophos, were successively banned. Pesticide The production, sale, and use of 23 substances, including fipronil, chloropicrin, and acephate, have been achieved. Pesticide Restricted use of the variety.
　　3 Our country Pesticide Identify issues in the evaluation process after registration.
　　 Pesticide As a post-registration evaluation Pesticide An important component of registration and management, it has evolved and improved over time in tandem with advances in society, the economy, and technology, as well as with the rising level of public awareness. In China, Pesticide Following registration, the evaluation process got off to a late start and rests on a weak foundation, with shortcomings in multiple areas.
　　3.1 Incomplete Policies and Regulations
　　2017《 Pesticide Prior to the revision of the Administrative Regulations, although the Food Safety Law stipulated that “the use of highly toxic and extremely toxic substances is prohibited,” Pesticide “It is used for crops such as vegetables, melons and fruits, tea, and traditional Chinese medicinal herbs,” but there is a lack of specific regulations and technical standards on how to implement it. As for highly toxic and high-risk substances… Pesticide , Safety incidents occur from time to time, attracting significant public attention; there is an urgent need to strengthen safety monitoring and assessment, and to carry out… Pesticide Risk monitoring efforts that provide critical information after registration and subsequent evaluation shall be based solely on the document issued by the General Office of the Ministry of Agriculture and Rural Affairs, “On Strengthening…” Pesticide “Notification on the Implementation of Security Risk Monitoring” is hereby issued.
　　3.2 Weak Operational Foundation
　　 Pesticide For a long time, safety monitoring has been carried out separately by multiple departments, including agriculture, health, environmental protection, and grain administration. Information exchange among these agencies has been limited, and in some localities, after incidents such as crop phytotoxicity, human and animal poisoning, or environmental pollution occur, relevant information is not reported promptly. Pesticide Post-registration evaluation lacks supporting case studies and data. Pesticide After registration, the primary sources of information are evaluated through domestic and international data, expert systems, Pesticide These include risk monitoring and validation testing. However, information systems and expert systems remain inadequate; no communication mechanism has yet been established with foreign re‑evaluation authorities; and risk monitoring suffers from an underdeveloped network, incomplete regulations, and shortages of personnel, funding, and resources.
　　3.3 Insufficient Risk Management
　　Our country Pesticide Prior to 2004, registration policies primarily focused on Pesticide The quality and efficacy of the product have been strengthened since 2004. Pesticide The safety requirements are governed by the principle of giving equal weight to “quality and safety.” Meanwhile, through retrieval… Pesticide Registration database: as of the end of 2018, cases registered for more than 15 years were included. Pesticide The number of active ingredients reaches 478, accounting for those that have been registered. Pesticide 72% of the total, involving products that account for Pesticide More than 90% of the total number of registered products. These… Pesticide The registration threshold for products in that year was relatively low, and there was limited data on safety assessments, making it difficult to meet current regulatory requirements, which resulted in… Pesticide The product registration documentation is incomplete, and the level of safety varies considerably.
　　3.4 Insufficient Management Experience
　　 Pesticide Post‑registration evaluation covers multiple aspects, including phytotoxicity, resistance, pesticide residues, the ecological environment, and human and animal health, and requires a thorough assessment of… Pesticide A thorough understanding of intrinsic characteristics, climate, cropping systems, and farmer practices requires the expertise of seasoned professionals who can identify and monitor these factors—knowledge that stems from long-term observation and the meticulous accumulation of data. In the specialized field, collaboration across disciplines such as agronomy, plant protection, chemistry, environmental science, and toxicology is essential; yet we urgently need to strengthen our capabilities in this area, as current realities reveal significant gaps. Pesticide The issues of unprofessionalism and instability within the registered workforce, coupled with a lack of practical experience in agricultural production.
　　4   Pesticide Reflections on Evaluative Work After Registration
　　4.1 Improve the legal framework for re-evaluation and refine the management mechanisms.
　　According to the newly revised… Pesticide Regulations on Administration,” and formulate “ Pesticide Re‑evaluation Management Measures》《 Pesticide In accordance with the Measures for the Administration of Risk Monitoring and other relevant provisions, further refine… Pesticide Reassess registration requirements, institutionalize routine risk monitoring, and standardize related aspects such as staffing, budgetary allocations, and division of responsibilities, while ensuring effective implementation at the provincial level. Pesticide The principal responsibilities of certification bodies and other relevant authorities, along with standardized management requirements. Based on registration data and monitoring results, where serious hazards or significant risks are identified, administrative measures such as revoking registration or imposing bans or restrictions shall be implemented, and highly toxic, high‑risk, or inefficient products shall be phased out in accordance with laws and regulations.
　　4.2 Establish a re‑evaluation registration procedure and standardize evaluation criteria.
　　Refer to international standards. Pesticide After registration, the prevailing practices are evaluated, and lessons are drawn from domestic pharmaceuticals, veterinary medicines, seed For each industry sector, management measures for registered products shall be established, along with corresponding re‑evaluation procedures and technical specifications. By incorporating risk‑assessment principles and exploring cost–benefit analyses, and by taking into account the risk profiles across four domains—agricultural production safety, agricultural product quality and safety, ecological environmental safety, and human and animal health safety—and considering China’s actual production and application conditions, appropriate evaluation principles and unified evaluation standards should be formulated. This will ensure that evaluation outcomes are scientific and impartial, and on this basis, a comprehensive system of re‑evaluation procedures and standards can be gradually developed.
　　4.3 Adhere to the integration of static and dynamic monitoring, and establish Pesticide Risk Database
　　Organize Pesticide Product registration data; organize and carry out activities related to registered products. Pesticide Monitoring the efficacy, safety, and cost-effectiveness of products, as well as collecting and analyzing information on safety incidents. Tracking real-world product performance to promptly obtain data on phytotoxicity, resistance, environmental hazards, pesticide residue exceedances, and human or animal poisoning, while establishing an online information platform for data collection. Pesticide Risk monitoring database, composed of Pesticide The management, production, and user departments shall submit regular or ad hoc reports on relevant matters. The Ministry of Agriculture and Rural Affairs shall establish a long-term monitoring mechanism and make timely public announcements. Pesticide Reassess the list of varieties and maintain close, ongoing monitoring. Pesticide Use with caution; any issues discovered must be reported promptly and handled appropriately.
　　4.4 Conduct periodic re-evaluations to achieve Pesticide “Weight loss”
　　For vehicles registered for more than 15 years Pesticide Varieties should actively gather domestic and international monitoring and research findings, identify potential risk points, and, when necessary, conduct joint validation trials. In accordance with current registration data requirements, information and data should be promptly supplemented and refined. Based on the level of risk and hazard, periodic re-evaluations should be organized in phases and batches. Research and development of alternative products should be encouraged, and support should be provided for the development of highly effective, low‑toxicity, and low‑residue solutions. Pesticide registration, accelerate promotion and application, implement highly toxic Pesticide The designated‑point operation system, coupled with the implementation of real‑name purchasing and traceability management, is helping to facilitate the orderly phase‑out of highly toxic and high‑risk substances such as aldicarb, promote capacity adjustments, and effectively reduce… Pesticide Varieties and product quantities, optimize dosage forms, adjust application methods, standardize application scopes, and truly achieve… Pesticide “Slimming down” contributes appropriately to the nation’s “dual reduction” policy and to the green development of agriculture.

Author: Liu Xue Source: Pesticide Inspection Institute, Ministry of Agriculture and Rural Affairs