China is one of the largest pesticide exporters in the world with exports of 1,440,000 tons in 2011. Chinese pesticides are however criticized by the international stakeholders for being inferior and of poor quality. To combat the dismal reputation of Chinese products, the government is developing new regulations. Although the final legal text of new pesticide regulation has not been published, inferences on its content and scope can be made based on statments made by officials from the ICAMA (the Institute for the Control of Agrochemicals, Ministry of Agriculture).
Boosted R&D Oriented and Environmental-friendly Players
The Chinese industry is saturated by small and medium sized companies producing a limited number of pesticides. Therefore, fierce competition and underselling of these pesticides to the overseas market is a common phenomenon. R&D activities are almost completely isolated to a number of the larger Chinese companies and of course multinational corportations.In China, pesticide companies are required to obtain both the ICAMA registration and the manufacturing permit issued by industrial authorities: the Ministry of Industry and Information Technology (MIIT) or the General Administration for Quality Supervision, Inspection and Quarantine (AQSIQ). Only manufacturing companies can be granted the ICAMA registration therefore there is little incentive for R&D. This dilemma will only be solved when registration for new pesticides can be applied for by non-manufacturing companies and the registration certification can be subsequently transferred to other manufacturers.
Furthermore, the “one registration certificate, one manufacturing permit” policy required by manufacturers is also likely to be relaxed. Under this potential ammendment if a pesticide company has been granted a manufacturing permit but not yet granted ICAMA registration, it can be commissioned by other ICAMA registration holders to manufacture the product if the two parties agree and are sanctioned by authorities prior to the start of manufacture. This also opens up the possibility of trading or transferring registration data from company to company.
Eco-friendly and bio-pesticide products are becoming the trend in the global crop protection market, products with the above characteristics will enjoy more benefits during the registration review. For example, principle of “trading space for time” will be applied to the field trial of the bio-pesticides. Currently, the field tests for bio-insecticide/fungicide products are required to be conducted at 4 sites for 2 years, the process can be expedited by conducting the test at 8 sites for 1 year. Impact on the environment, food safety and occupation health will be considered during the registration process. China will build evaluating models for risk assessment on pesticide in environment, ecological, occupational health and residues in food. Risk level will be determined by calculation and deduction through the evaluation models. Negative review outcomes can still be reassesed if the applicant can provide evidence to the contrary based on alternative risk assessment. Hence products with poor environmental and health profiles will require more data and more studies than the eco-friendly products.
For the pesticides for exporting purpose, there will be separate data requirements for pesticide registration.
Data Gathering and Testing Facilities
5-Batch data should be taken in the production facility from which the samples are taken, however there are numerous reports of false 5-batch data being generated in laboratories or data generated using results from samples taken in other factories. Other issues relating to incorrect storage and preparation have also been encountered. As planned by the policymakers, future issuance of the “Measures of Sample Management for Testing Facilities” will detail how the samples should be obtained, transported, stored, prepared and disposed. This would be helpful to improve the credibility of the data generated from the testing facilities in China.
Currently, the testing facilities for pesticide registration are administrated in China via numerous ministries an. They are either subject to the MoA’s “Provision of testing facilities for pesticide registration” or the GLP rules for agrochemicals. Unified GLP rules are expected to be implemented to these testing facilities. Although China has tacitly accepted the data from GLP-compliant facilities since the 1980’s, the acceptance of data from the “Mutually Acceptance of Data system (MAD)” will be incorporated in legal provision first time ever. As China’s increasingly participating international exchanges and cooperation on OECD’s GLP principles in recent years, full incorporation into the MAD system would be concluded if China harmonize its own GLP authorities among different Ministries and Departments such as the MoA, SFDA, MEP and Certification and Accreditation Administration of the People’s Republic of China. Another challenge is the gap between data to be gathered and the scarcity of GLP facilities. Perhaps a stepwise implementation of GLP would be more practical. It would be expected that the data for new pesticide registration would be firstly required to be generated by the GLP-compliant facilities.
Stringent Control on Product Quality
Problems of quality defects of pesticides are threatening food supplies and the reputation of “Made in China”, which can be ascribed to poor quality control on the raw materials, processing technology and storage of agrochemical products. Practices of quality control of pharmaceuticals and veterinary drugs will be borrowed by the agrochemical authority. The MoA will establish quality specifications and inspection methods on the registered pesticides, focusing on the appearance, physical-chemical indicators, and stability requirements of the products. To increase the credibility of the test report, method validation will be introduced. The pesticide companies would be required to verify the linearity, accuracy, precision of their testing methods and the validation report will be issued by the testing facilities.
Due to the increasing occurrence of crop injuries, China will analyze the causes of the impurities from the synthesis of the ais and productions of formulated products. The authority will stepwise publish the “List of Relative Impurities of Pesticide” and “Catalogue and Classification of Adjuvant for Crop Protection Products”.
Purging the Terminal Market
China’s terminal crop protection market consists of nearly 350, 000 distributors and millions of consumers. However, only half of the distributors have been educated and most of them are incapable of giving professional guidance on proper uses of the pesticide. Excessive and illegal uses of pesticide are weakening China’s trade competitiveness in agricultural commodities. To combat the problems, a licensing system will be imposed on pesticide distributors in the future. The restricted pesticides will only be purchased from appointed distributors and “real name purchasing” will be imposed on the highly toxic products. Furthermore, efforts will be expanded to train the pesticide manufacturers and marketing personnel. The low-toxic bio-pesticides, direct-chain distributors and professional pest control services will be given more political, financial and governmental support.
Pesticides doped with covert and unregistered active ingredients would be identified as the counterfeits and the manufacturers might be revoked of registration certification and manufacturing permit. Meanwhile, the MoA will establish detecting method for several ais, most of which are targeting ais covertly added into the formulated products. The spot check on the circulated products will be more regular and be more concentrated on the suspect adding of ais other than conventional quality control items.
Although final version of the legal text has been approved by the Standing Committee of the State Council and prepared for issuance, much more detailed supporting documents and provisions are in urgent need to be revised and established. Another unresolved concern is the competent authority for “manufacturing permit”. The power to supervise the permit will land upon either the MIIT or the AQSIQ.