158.1020—Applicator exposure data requirements table.
(a) General.
Sections 158.100 through 158.130 describe how to use this table to determine the applicator exposure data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
(b) Use patterns.
(1)
Occupational use patterns include products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, terrestrial nonfood crop, aquatic food, aquatic nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food use, and indoor nonfood use. Occupational use patterns also include commercial (“for hire”) applications to residential outdoor and indoor sites.
(2)
Residential use patterns include residential outdoor use and residential indoor use. These use patterns are limited to nonoccupational, i.e., nonprofessional, pesticide applications.
(d) Table.
The data requirements listed pertain to pesticide products that meet the testing criteria outlined in § 158.1010. The table notes are shown in paragraph (e) of this section.
| Guideline Number | Data requirement | Use pattern | Test substance | Test Note No. | |
|---|---|---|---|---|---|
| Occupational | Residential | ||||
| 875.1100 | Dermal outdoor exposure | R | R | TEP | 1, 2, 3 |
| 875.1200 | Dermal indoor exposure | R | R | TEP | 1, 2, 4 |
| 875.1300 | Inhalation outdoor exposure | R | R | TEP | 1, 2, 3 |
| 875.1400 | Inhalation indoor exposure | R | R | TEP | 1, 2, 4 |
| 875.1500 | Biological monitoring | CR | CR | TEP | 1, 2 |
| 875.1600 | Data reporting and calculations | R | R | TEP | 5 |
| 875.1700 | Product use information | R | R | TEP | -- |
(e) Test notes.
The following notes apply to the data requirements in the table to paragraph (d) of this section:
1. Protocols must be submitted for approval prior to the initiation of the study. Details for developing protocols are available from the Agency.
2. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data, provided the human pharmacokinetics of the pesticide and/or metabolite/analog compounds (i.e., whichever method is selected as an indicator of body burden or internal dose) allow for the back calculation to actual dose.
3. Data are required if the product is applied outdoors.
4. Data are required if the product is applied indoors.
5. Data reporting and calculations are required when handler exposure data are submitted.