ABSTRACT

This chapter discusses the regulations and toxicology testing proposed by the Environmental Protection Agency (EPA) for the registration of biorationals. Five general areas are covered by EPA requirements: acute toxicity, irritation, genotoxicity, hypersensitivity, and cellular immune response. Three chronic toxicity studies, oral, dermal, and inhalation, are required for all manufacturing-use and formulated products. Acute Inhalation Toxicity study is conducted to obtain data pertinent to the registration of manufacturing-use and formulated products. Two examples of biorational insect growth regulators are kinoprene and methoprene. The microbial agent is used to control plant growth and development, phytotoxicity, germination/seedling emergence, vegetative vigor, and growth and reproduction of aquatic plants, the safety of and possible hazards from the use of microbial agents depending on the agent, its specificity and mode of application, and the geographic area in which it is used. Testing is required to support the registration of microbial agents classified as manufacturing-use and formulated products.