ENVIRONMENTAL RISK ASSESSMENT OF PESTICIDES - IMPROVING SIMULATION-MODEL CREDIBILITY

Registrant use of computer simulation modeling is generally accepted by regulators in lieu of some experimental data for risk assessment, provided worst-case assumptions and extremely conservative criteria for negligible risk are used. These requirements taken together mean that only extreme cases escape the requirement for actual environmental data. This conservatism reflects the uncertainty in both exposure estimates by the models and in the hazard estimates from toxicologists. Until the credibility of estimated environmental concentrations given by models is improved by, more experimental data and experience on the part of both registrants and regulators, the models will continue to be considered not-validated by many. There are four current developments that provide a compromise between the two impossible extremes of total model validation and total field. measurement: (1) as models develop more process detail the parameters become more fundamental in nature and these are generally more amenable to independent estimation or measurement; (2) the reporting of probabilistic analyses and probable errors of results by modelers will enhance credibility; (3) the development of data sets for specific crop/site/pesticide/weather scenarios will allow users to modify those parts of the input they are concerned with while retaining confidence that parameters with which they are unfamiliar will have reasonable values; and (4) meso-scale and micro-scale physical simulation experiments can fill the gap between laboratory and field results. The most important need for enhancing model credibility is full access by the pesticide science community to all the information available, so that we may increase our understanding. Legal mechanisms should be considered for longer ownership of exclusive marketing rights of active ingredients, in exchange for complete public disclosure of the environmental fate and toxicology data submitted to regulatory agencies.