chapter  21
22 Pages

Chemical Toxicity Testing and Risk Assessment Practice in China

Environmental Sciences (CRAES), and the Medical College of Peking University in 2004. The first revision has been in progress since 2011. The HJ/T154 covers the identification of physical hazards, health hazards, and environmental hazards of new chemical substances [14-18]. The Guidelines for Risk Assessment of Chemicals, currently being compiled by the CRAES, also cover the principles, procedures, methods, and technological requirements of chemical risk assessment [16]. 21.3 AgrochemicalsAn “agrochemical” (or “agrichemical”), a generic term for the various chemical products used in agriculture, refers to the broad range of pesticides, including insecticides, herbicides, and fungicides. It may also include synthetic fertilizers, hormones, and other chemical growth agents. In China, plant protection products and a majority of biocidal products are regulated by China’s pesticide management law and administered by the MOA in China. Some biocidal products such as disinfectants are regulated by the MOH. This section mainly describes toxicity testing and risk assessment of pesticides in China [19]. Beginning with the production of chlorinated hydrocarbons in the late 1950s, the Chinese pesticide industry has developed by leaps and bounds, making remarkable progress especially in the recent decade, and now has formed a complete system, including pesticide research and development and intermediate materials and formulation production. There are about 2600 pesticide producers (including those producing insecticides for public health services) in China, with a production capacity of 850,000 tons (counted in 100%) of over 600 varieties, 800,000 tons of formulation, and over 20,000 formulated products, becoming the largest consumer and the second-largest pesticide-producing country in the world, whose annual output reached 3.6 million tons in 2012, with an increase of 34% in the same period in 2013 [20, 21]. 21.3.1 Regulations

Pesticides in China are regulated by three main regulations:

The Regulation on Pesticide Administration (RPA), which was issued by the State Council on May 8, 1997, is the principle rule of pesticide management in China. This regulation regulates the pesticide registration and all the pesticides produced in China or imported to China that must be registered. The regulation also requires production licensing, which means pesticide production in China must obtain a production license or a document of approval. On November 29, 2001, the RPA was revised to meet the requirements of entering the World Trade Organization (WTO). In July 2004, the regulation was revised again. The Implementation Procedure Regulation on Pesticides Administration was issued by the MOA on April 27, 1999. The Data Requirement of Pesticide Registration (DRPR) was issued by the MOA on April 12, 2001, and revised on December 8, 2007. There are also some other laws and rules concerning pesticides management, such as the Product Quality Law, the Standardization Law, the Advertisement Law, and the Regulation on Hazardous Chemicals Management, among others. The related local governments and departments also established relevant rules and regulations to comply with the RPA. Every province and municipality directly under the central government and autonomic administration regions issued its local regulations on pesticide administration. The MOA and the MOH issued the Guideline on Pesticide Safe Use to specify and harmonize with the RPA. All these constitute a legal system of pesticide management [19-21]. 21.3.2 Toxicity Testing

21.3.2.1 Test agencyThe Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA) was established in 1963 as an institution affiliated with the MOA, which specializes in nationwide pesticide registration and administration with the main responsibilities for registration, quality control, bioassay and residue monitoring of pesticides, supervision of pesticide markets, information service, technical exchange, and international cooperation and consultation.