Applicator exposure data described in paragraph (d) of this section are required based on toxicity and exposure criteria. Data are required if a product meets, as determined by the Agency, at least one 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 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 handling of the pesticide.

(b) Exposure criteria. (1) Dermal exposure may occur during the prescribed use.

(2) Respiratory exposure may occur during the prescribed use.