Registration exposure study standards

Preparing a detailed protocol according to GLP standards may be useful for researchers planning a worker exposure or re-entry study, even though the study may never be submitted to the EPA to support the registration of a pesticide product. Having a detailed protocol helps to solidify one s plans for the study, and assists in the documentation phase of the study. This documentation phase will be addressed in some detail later. 

A search of federally funded research in progress (FEDRIP 2000) revealed several studies that are discussed in this section. Creosote is currently subject to a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration standard and data call-in by EPA. In addition, the Creosote Council II is planning to conduct a research program that includes testing for worker exposure and protection. 

China. Japan remains focused on possible genetic differences, and continues to insist upon studies conducted in its own population as a condition for registration and approval. Regional variations, such as diet, alcohol and tobacco consumption, climate, exposure to pollution and other environmental factors, socioeconomic status, and differences in technology and health care standards, require creative planning for multinational trials. 

More recent studies, and especially those submitted In support of new registrations, exhibit a wide variation In the location and number of patches used to measure Impingement on different body parts and In the method for determining exposure. Closer analysis of these studies must be carried out before a "standardized protocol Is adopted. It remains to be determined whether the variations seen are due to true variations In exposure (due to personal handling differences, formulation type or wind) or whether they simply reflect differences In the method of calculation of the data. 

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