Biochemical pesticides human health assessment data requirements table.

§ 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
870.1100Acute oral toxicity - ratRRTGAI and MPTGAI and EP1
870.1200Acute dermal toxicityRRTGAI and MPTGAI and EP1, 2
870.1300Acute inhalation toxicity - ratRRTGAI and MPTGAI and EP3
870.2400Primary eye irritation - rabbitRRTGAI and MPTGAI and EP2
870.2500Primary dermal irritationRRTGAI and MPTGAI and EP1, 2
870.2600Dermal sensitizationRRTGAI and MPTGAI and EP2, 4
noneHypersensitivity incidentsRRAllAll5
Subchronic Testing
870.310090-day oral (one species)RCRTGAITGAI6
870.325090-day dermal - ratCRCRTGAITGAI7
870.346590-day inhalation - ratCRCRTGAITGAI8
Developmental Toxicity
870.3700Prenatal developmental - rat preferablyRCRTGAITGAI9
Mutagenicity Testing
870.5100Bacterial reverse mutation testRCRTGAITGAI10
870.5300
870.5375
In vitro mammalian cell assayRCRTGAITGAI10, 11
Tier II
Mutagenicity Testing (In vivo cytogenetics)
870.5385
870.5895
In vivo Mammalian CytogeneticsCRCRTGAITGAI13
Developmental Toxicity
870.3700Prenatal developmentalCRCRTGAITGAI9
Special Tests
880.3550ImmunotoxicityCRCRTGAITGAI12, 13
Applicator/User Exposure
875.1100Dermal outdoor exposureCRCRTGAITGAI15
875.1200Dermal indoor exposureCRCRTGAITGAI15
875.1300Inhalation outdoor exposureCRCRTGAITGAI15
875.1400Inhalation indoor exposureCRCRTGAITGAI15
875.1500Biological monitoringCRCRTGAITGAI15
Tier III
Chronic Testing/Special Testing
880.3800Immune responseCRCRTGAITGAI14
870.3800Reproduction and fertility effectsCRCRTGAITGAI16
870.4100Chronic oral - rodent and nonrodentCRCRTGAITGAI17
870.4200Carcinogenicity - two species - rat and mouse preferredCRCRTGAITGAI18
870.5380Mammalian spermatogonial chromosome aberration testCRCRTGAITGAI19
Special Testing
870.7200Companion animal safetyCRCRNRTGAI or EP20
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