158.2083—Experimental use permit 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 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 experimental use permit biochemical pesticides human health assessment. The test notes are shown in paragraph (e) of this section.

Table—EUP Biochemical Pesticides Human Health Assessment Data Requirements

Guideline Number	Data Requirement	Use Patterns		Test Substance		Test Notes
Guideline Number	Data Requirement	Food	Nonfood	MP	EP	Test Notes
Tier I
Acute Testing
Code of Federal Regulations 153
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
none	Hypersensitivity incidents	R	R	All	All	4
Subchronic Testing
870.3100	90-day oral (one species)	R	NR	TGAI	TGAI	--
Developmental Toxicity
870.3700	Prenatal developmental - rat preferably	R	CR	TGAI	TGAI	5
Mutagenicity Testing
870.5100	Bacterial reverse mutation test	R	CR	TGAI	TGAI	6
870.5300	In vivo mammalian cell assay	R	CR	TGAI	TGAI	6, 7
Tier II
Developmental Toxicity
870.3700	Prenatal developmental	CR	CR	TGAI	TGAI	5

(e) Test notes. The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides human health assessment as referenced in the last column of the table in paragraph (d) of this section.

1. Required unless the test material is a gas or highly volatile (vapor pressure > 10-4torr (mm/Hg)).

2. Required unless the test material is corrosive to skin or has pH <2 or >11.5.

3. Required when the pesticide, under conditions of use, would result in respirable material (e.g., gas, volatile substance or aerosol/particulate), unless it is a straight chain lepidopteran pheromone.

4. Hypersensitivity incidents must be reported as adverse effects data.

5. Required if the use of the product under widespread and commonly recognized practice may reasonably be expected to result in significant exposure to female humans (e.g., occupational exposure or repeated application of insect repellents directly to the skin). Tier II data is required on a different test species from Tier I data when developmental effects are observed in the first study and information on species-to-species extrapolation is needed.

6. Required to support nonfood uses if either:

i. The use is likely to result in significant human exposure; or

ii. The active ingredient (or its metabolites) is structurally related to a known mutagen or belongs to any chemical class of compounds containing a known mutagen.

Additional mutagenicity tests that may have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the available evidence.

7. Choice of assay using either:

i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, maximizing assay conditions for small colony expression or detection;

ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) gene locus, accompanied by an appropriate in vivo test for clastogenicity; or

iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.

CFR

158.2083—Experimental use permit biochemical pesticides human health assessment data requirements table.