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5 Conclusions and Recommendations
Pages 70-75

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From page 70...
... The subcommittee agrees that development of a risk characterization, and subsequent risk assessment, is an appropriate approach to be used to protect agricultural workers and the general population from potential adverse effects associated with this widely used pesticide. Below are specific conclusions reached by the subcommittee based on DPR's presentation of the toxicology, exposure, and risk assessment and risk appraisal information for methyl bromide as detailed in DPR's report.
From page 71...
... · The rabbit developmental study had toxicity endpoints of gallbladder agenesis and fused sternebrae, which are not considered major malformations; however, the subcommittee feels that these are indicators of developmental toxicity, and therefore, are appropriate endpoints for the developmental RfC (Breslin et al.
From page 72...
... · In general, the subcommittee is highly critical of the analysis and presentation of the available exposure data, finding it seriously deficient in understanding and application of modern concepts of variability and uncertainty, and in the fair evaluation of the magnitude and distribution of existing exposures relative to exposure levels intended to be achieved by current regulatory controls. · There is considerable room for improvement in the methods used by DPR to obtain monitoring data, particularly with regard to good measurement techniques and sampling strategies that assess variability of actual exposure.
From page 73...
... · Identify the best analytical methods for determining methyl bromide concentrations in air under a variety of field conditions. The entire risk assessment process is fundamentally dependent on the quality of the analytical information on exposure conditions.
From page 74...
... The subcommittee believes that the toxicity endpoints used might be overly conservative due to their equivocal nature, but also believes that the exposure assessments might understate the actual exposures, particularly for residents living near fields where methyl bromide is applied. · The subcommittee agrees that DPR's use of factors of ~ O for intraspecies variation and for animal to human variation, as well as a benchmark margin of exposure (MOE)
From page 75...
... ~ To protect workers and residents from the adverse effects of methyl bromide, DPR must be more explicit about linking its methodology for exposure and MOE analysis to the regulatory levels that are based upon the risk assessment or MOE values. The subcommittee recommends that DPR state at the beginning of its risk characterization document the regulatory goals it hopes to achieve and how its risk characterization will meet them.


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