For nonfood use pesticides only, applicants have two options for generating and submitting required toxicology (§ 158.500) and human exposure (§ 158.1020, § 158.1070, and § 158.1410) studies. Applicants are to select one of the following:
(a) Acute, subchronic, chronic, and other toxicological studies on the active ingredient must be submitted together. The specific makeup of the set of toxicology study requirements is based on the anticipated exposure to the pesticide as determined by the Agency. If hazards are identified based upon review of these studies, specific exposure data will be required to evaluate risk.
(b) Certain toxicological and exposure studies must be submitted simultaneously with the toxicology data submitted in a tiered system. Exposure data must be submitted along with first tier toxicology data. The requirement for additional second and third level toxicology testing will be determined by the Agency based on the results of the first tiered studies.
(1) The required first-tier toxicology studies consist of:
(i) Battery of acute studies.
(ii) A subchronic 90-day dermal study or a subchronic 90-day inhalation study.
(iii) An acute and subchronic neurotoxicity screening battery in the rat.
(iv) Prenatal developmental toxicity studies in both the rat and rabbit.
(v) Reproduction and fertility studies in rats.
(vi) Battery of mutagenicity studies.
(vii) Immunotoxicity study.
(2) The conditionally required second-tier studies include:
(i) Subchronic 90-day feeding studies in both the rodent and nonrodent.
(ii) Dermal penetration study.
(3) The conditionally required third-tier studies include:
(i) Chronic feeding studies in the rodent.
(ii) Carcinogenicity.
(iii) Metabolism study.
(iv) Additional mutagenicity testing.