Reentry data requirements

There has been a push for direct data collection (DDC) as an alternative to remote data capture (RDC). In this approach most of the required clinical data are acquired directly from existing patient record systems such as MRI machines, ECG, EEG, TTM, laboratories, and other measurement equipment. This approach eliminates the need for paper transcription and reentry to another system. It promises error-free and resource-efficient data capture, which allows early locking of the database and therefore potentially earlier product launch [30]. 

Dermal Exposure Levels. Setting acceptable maximum dermal exposure levels to specific pesticides has been difficult. This is primarily due to a lack of specific data on dermal transport rates for specific pesticides as related to adverse effect levels and presumed no-effect levels. We are now requiring such data from the registrants, and our Department has a suggested protocol (1) that is offered to registrants that will provide such information from animal exposure studies. This dermal transport rate information is important in setting minimum field reentry intervals for field workers as well as in evaluating exposure levels of mixers, loaders, and applicators. 

The EPA is in the process of developing reentry guidelines. As I mentioned previously, the basic thrust is to require data to establish reentry intervals. There are two points to be made concerning this endeavor ... 

The following are some of the data that may be required by CDFA to assist in making exposure estimates of persons involved in various activities involving the use of pesticides indoor exposure field reentry mixer, loader, and applicator exposure, dermal absorption, and dermal dose response data. 

Reentry intervals are now established on the basis of (1) data on dermal absorption or dermal dose response (2) inhalation, dermal, and oral acute toxicity studies in animal models (3) foliar and soil residue dissipation data and, (4) available human exposure data. CDFA recommends several sources as useful guides for determining residues of pesticides on soil and leaf surfaces (dislodgeable residue) and conducting field reentry studies involving human volunteers (1-5). Human exposure studies may not be required if adequate animal data from (1) through (3) above are... 

Figure 6.34 Models of stem reentry for chain sequences in a lameiiar-shaped crystal, (a) Regular reentry with superfolding (b) partial nonadjacency (stem dilution) as required by closer matching of the experimental data in accord with Yoon and Flory (c) adjacent stem positions without superfolding (d) the switchboard model. All reentry is along the (121) plane superfolding is along adjacent (121) planes. View is from the (001) plane, indicated by dots (122).

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