Pesticide registration toxicology requirements

The emphasis of these position papers was primarily in the toxicology area. However, it became clear as time passed that GLPs needed to be addressed with respect to other studies required for pesticide registration, namely, the chemistry studies. This then brings me to the current topic of this symposium. 

Brassinosteroids, therefore, would qualify for classification as biochemical pesticides. Once they are classified as biochemical pesticides, the data requirements for U.S. registration would be significantly reduced (because of a tier approach), especially in the areas of toxicology, ecology and wildlife, and environmental fate. Because of their low use volume, brassinosteroids are unlikely to leave any residues in crops, and they would qualify for exemption from the requirement of a tolerance. If that were the case, what applicants seeking U.S. registrations need to do is to develop data on product chemistry and acute toxicology, as well as use profiles for their products, which will be dealt with on a case-by-case basis. 

Environmental Protection Agency (1982) Pesticides registrations proposed data requirements. Sec. 158.135 toxicology data requirements. Federal Regulations 47 53192 Feldman RJ, Maibach HI (1967) Regional variation in percutaneous penetration of [ " C] cortisone in man. J Invest Dermatol 48 181-183... 

In 1988 there were amendments to FIFRA requiring EPA to accelerate the reregistration of all pesticides registered before 1984. By current standards, earlier test protocols were considered to be insufficient to satisfy the safety concerns of the present. Data gaps, toxicological and environmental, in the earlier registrations were required to be eliminated to permit reregistration of hundreds of currently used compositions. 

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