Exposure data described in § 158.1070(d) are required based upon toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, either or both of the toxicity criteria in paragraph (a) of this section and either or both of the exposure criteria in paragraph (b) of this section.
(a) Toxicity criteria.
(1) Evidence of potentially significant adverse health effects have been observed in any applicable toxicity study.
(2) Scientifically sound epidemiological or poisoning incident data indicate that adverse health effects may have resulted from post-application exposure to the pesticide.
(b) Exposure criteria. The need for data from potential exposure resulting from situations not covered by this paragraph should be discussed with the Agency.
(1) For outdoor uses.
(i) Occupational human post-application exposure to pesticide residues on plants or in soil could occur as the result of cultivation, pruning, harvesting, mowing or other work-related activity. Such uses include agricultural food, feed, and fiber commodities, forest trees, ornamental plants, and turf grass.
(ii) Residential human post-application exposure to pesticide residues on plants or in soil could occur. Such uses may include turf grass, fruits, vegetables, and ornamentals grown at sites, including, but not limited to, homes, parks, and recreation areas.
(2) For indoor uses.
(i) Occupational human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at agricultural or commercial sites, such as, but not limited to, agricultural animal facilities and industrial or manufacturing facilities.
(ii) Residential human post-application exposure to pesticide residues could occur following the application of the pesticide to indoor spaces or surfaces at residential sites, such as, but not limited to homes, daycare centers, hospitals, schools, and other public buildings.