CFR

158.260—Experimental use permit data requirements for environmental fate.

All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.

(a) Use patterns. (1) The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern includes the general use patterns of aquatic food crop, aquatic nonfood residential, and aquatic nonfood outdoors. The greenhouse use pattern includes both food and nonfood uses. The indoor use pattern includes food, nonfood, and residential indoor uses.

(2) Data are also required for the general use patterns of forestry use and residential outdoor use.

(b) Key. CR=Conditionally required; NR=Not required; R=Required; PAIRA=Pure active ingredient radio-labeled; TGAI=Technical grade of the active ingredient.

(c) Table. The following table shows the experimental use data requirements for environmental fate. The test notes are shown in paragraph (d) of this section.

Table—Experimental Use Permit Environmental Fate Data Requirements

Guideline No.	Data Requirement	Use Pattern						Test substance	Test Note No.
Guideline No.	Data Requirement	Terrestrial	Aquatic	Greenhouse	Indoors	Forestry	Residential Outdoors	Test substance	Test Note No.
Degradation Study - Laboratory
835.2120	Hydrolysis	R	R	R	NR	R	R	TGAI or PAIRA	1
Metabolism Studies - Laboratory
835.4100	Aerobic soil	R	CR	NR	NR	R	NR	TGAI or PAIRA	2
835.4300	Aerobic aquatic	NR	R	NR	NR	NR	NR	TGAI or PAIRA	--
Mobility Study
835.1230835.1240	Leaching and adsorption/desorption	R	NR	NR	NR	R	NR	TGAI or PAIRA	3

(d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section.

1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives.

2. Required for aquatic uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to cranberry bogs and rice paddies.

3. Adsorption and desorption using a batch equilibrium method is preferred. However, in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.

Code of Federal Regulations

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]

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