§ 158.2050 Biochemical pesticides human health assessment data requirements table.
(a) General. (1) Sections 158.100 through 158.130 describe how to use this table to determine the biochemical human health assessment data requirements for a particular biochemical pesticide product.
(2) The data in this section are not required for straight chain lepidopteran pheromones when applied up to a maximum use rate of 150 grams active ingredient/acre/year.
(b) Use patterns. (1) Food use patterns, in general, include products classified under the following general uses: terrestrial food crop use; terrestrial feed crop use; aquatic food crop use; greenhouse food crop use.
(2) Nonfood use patterns include products classified under the general use patterns of terrestrial nonfood crop use; aquatic nonfood residential use; aquatic nonfood outdoor use; aquatic nonfood industrial use; greenhouse nonfood crop use; forestry use; residential outdoor use; residential indoor use; indoor food use; indoor nonfood use; indoor medical use.
(c) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; Residue of concern = the active ingredient and its metabolites, degradates, and impurities of toxicological concern; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:
(d) Table. The following table shows the data requirements for biochemical pesticides human health assessment. The test notes are shown in paragraph (e) of this section.
Table—Biochemical Pesticides Human Health Assessment Data Requirements
Guideline Number | Data Requirement | Use Patterns | Test Substance | Test Notes | ||
---|---|---|---|---|---|---|
Food | Nonfood | MP | EP | |||
Tier I | ||||||
Acute Testing | ||||||
870.1100 | Acute oral toxicity - rat | R | R | TGAI and MP | TGAI and EP | 1 |
870.1200 | Acute dermal toxicity | R | R | TGAI and MP | TGAI and EP | 1, 2 |
870.1300 | Acute inhalation toxicity - rat | R | R | TGAI and MP | TGAI and EP | 3 |
870.2400 | Primary eye irritation - rabbit | R | R | TGAI and MP | TGAI and EP | 2 |
870.2500 | Primary dermal irritation | R | R | TGAI and MP | TGAI and EP | 1, 2 |
870.2600 | Dermal sensitization | R | R | TGAI and MP | TGAI and EP | 2, 4 |
none | Hypersensitivity incidents | R | R | All | All | 5 |
Subchronic Testing | ||||||
870.3100 | 90-day oral (one species) | R | CR | TGAI | TGAI | 6 |
870.3250 | 90-day dermal - rat | CR | CR | TGAI | TGAI | 7 |
870.3465 | 90-day inhalation - rat | CR | CR | TGAI | TGAI | 8 |
Developmental Toxicity | ||||||
870.3700 | Prenatal developmental - rat preferably | R | CR | TGAI | TGAI | 9 |
Mutagenicity Testing | ||||||
870.5100 | Bacterial reverse mutation test | R | CR | TGAI | TGAI | 10 |
870.5300 870.5375 | In vitro mammalian cell assay | R | CR | TGAI | TGAI | 10, 11 |
Tier II | ||||||
Mutagenicity Testing (In vivo cytogenetics) | ||||||
870.5385 870.5895 | In vivo Mammalian Cytogenetics | CR | CR | TGAI | TGAI | 13 |
Developmental Toxicity | ||||||
870.3700 | Prenatal developmental | CR | CR | TGAI | TGAI | 9 |
Special Tests | ||||||
880.3550 | Immunotoxicity | CR | CR | TGAI | TGAI | 12, 13 |
Applicator/User Exposure | ||||||
875.1100 | Dermal outdoor exposure | CR | CR | TGAI | TGAI | 15 |
875.1200 | Dermal indoor exposure | CR | CR | TGAI | TGAI | 15 |
875.1300 | Inhalation outdoor exposure | CR | CR | TGAI | TGAI | 15 |
875.1400 | Inhalation indoor exposure | CR | CR | TGAI | TGAI | 15 |
875.1500 | Biological monitoring | CR | CR | TGAI | TGAI | 15 |
Tier III | ||||||
Chronic Testing/Special Testing | ||||||
880.3800 | Immune response | CR | CR | TGAI | TGAI | 14 |
870.3800 | Reproduction and fertility effects | CR | CR | TGAI | TGAI | 16 |
870.4100 | Chronic oral - rodent and nonrodent | CR | CR | TGAI | TGAI | 17 |
870.4200 | Carcinogenicity - two species - rat and mouse preferred | CR | CR | TGAI | TGAI | 18 |
870.5380 | Mammalian spermatogonial chromosome aberration test | CR | CR | TGAI | TGAI | 19 |
Special Testing | ||||||
870.7200 | Companion animal safety | CR | CR | NR | TGAI or EP | 20 |