40 CFR 158.1070 - Post-application exposure data requirements table.
(a)General. Sections 158.100 through 158.130 describe how to use this table to determine the post-application 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.
(1) Occupational use patterns include products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, terrestrial nonfood use, aquatic food, aquatic nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food, and indoor nonfood. Occupational use patterns also include commercial (“for hire”) applications to residential outdoor and indoor sites.
(2) Residential use patterns include residential outdoor use and indoor residential use. These use patterns are limited to nonoccupational, i.e., nonprofessional, pesticide applications.
(c)Key. R = Required; CR = Conditionally required; NR = Not required; TEP = Typical end-use product.
(d)Table. The data requirements listed in the following table pertain to pesticide products that meet the testing criteria outlined in § 158.1060. The table notes are shown in paragraph (e) of this section.
Table - Post-Application Exposure Data Requirements
|Guideline Number||Data Requirement||Use Pattern||Test Substance||Test Note No.|
|875.2100||Dislodgeable foliar residue and turf transferable residues||R||R||TEP||1, 2, 3, 4, 5|
|875.2200||Soil residue dissipation||R||CR||TEP||1, 2, 6, 7|
|875.2300||Indoor surface residue dissipation||R||R||TEP||1, 2, 8, 9|
|875.2400||Dermal exposure||R||R||TEP||1, 2, 10, 11, 12|
|875.2500||Inhalation exposure||R||R||TEP||1, 10, 11, 12|
|875.2600||Biological monitoring||CR||CR||TEP||1, 12, 13|
|875.2700||Product use information||R||R||TEP||--|
|875.2800||Description of human activity||R||R||TEP||--|
|875.2900||Data reporting and calculations||R||R||TEP||14|
|875.3000||Nondietary ingestion exposure||NR||R||TEP||1, 11, 15|
(e)Test notes. The following test 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. Bridging applicable residue dissipation data to dermal exposure data is required.
3. Turf grass transferable residue dissipation data are required when pesticides are applied to turf grass. Dislodgeable foliar residue dissipation data are required when pesticides are applied to the foliage of plants other than turf grass.
4. Data are required for occupational sites if (i) there are uses on turf grass or other plant foliage, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated foliage while participating in typical activities.
5. Data are required for residential sites if there are uses on turf grass or other plant foliage.
6. Data are required for occupational sites, if (i) there are outdoor or greenhouse uses to or around soil or other planting media, and (ii) the human activity data indicate that workers are likely to have post-application dermal contact with treated soil or planting media while participating in typical activities.
7. Data are required for residential sites if the pesticide is applied to or around soil or other planting media both outdoors and indoors, e.g., residential greenhouse or houseplant uses.
8. Data are required for occupational sites if the pesticide is applied to or around on non-plant surfaces, e.g., flooring or countertops, and if the human activity data indicate that workers are likely to have post-application dermal contact with treated indoor surfaces while participating in typical activities.
9. Data are required for residential sites if the pesticide is applied to or around non-plant surfaces, e.g., flooring and countertops.
10. Data are required for occupational sites if the human activity data indicate that workers are likely to have post-application exposures while participating in typical activities.
11. Data are required for residential sites if post-application exposures are likely.
12. Biological monitoring data may be submitted in addition to, or in lieu of, dermal and inhalation exposure data provided the human pharmocokinetics 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 a back-calculation to the total internal dose.
13. Data are required when passive dosimetry techniques are not applicable for a particular exposure scenario, such as a swimmer exposure to pesticides.
14. Data reporting and calculations are required when any post-application exposure monitoring data are submitted.
15. The selection of a sampling method will depend on the nondietary pathway(s) of interest. Data must be generated to consider all potential pathways of nondietary ingestion exposure that are applicable (e.g., soil ingestion, hand-to-mouth transfer, and object-to-mouth transfer of surface residues).