40 CFR 158.2084 - Experimental use permit biochemical pesticides nontarget organisms and environmental fate data requirements table.

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§ 158.2084 Experimental use permit biochemical pesticides nontarget organisms and environmental fate data requirements table.

(a)General.

(1) Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms and fate data requirements for a particular biochemical pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section. In general, for all outdoor end-use products including turf, the following studies are required: one avian acute oral, one avian dietary, one acute freshwater fish, and one acute freshwater invertebrate study.

(2) The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species (i.e., granular formulation).

(b)Use patterns. The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and nonfood use. The remaining terrestrial uses include forestry and residential outdoor use. Data are also required for the general use patterns of aquatic food and nonfood crop 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 nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.

Table - EUP Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements

Guideline Number Data Requirement Use Patterns Test Substance Test Notes
Terrestrial Aquatic Greenhouse Forestry, Residential Outdoor Indoor
Food/Feed/Nonfood Food/Nonfood Food/Nonfood Food/Nonfood
Tier I
Avian Testing
850.2100 Avian acute oral toxicity R R NR R NR TGAI, EP 1, 2, 3
850.2200 Avian dietary toxicity R R NR R NR TGAI, EP 1, 2, 3
Aquatic Organism Testing
850.1075 Fish acute toxicity, freshwater R R NR R NR TGAI, EP 2, 3, 4
850.1010 Aquatic invertebrate acute toxicity, freshwater R R NR R NR TGAI, EP 2, 4

(e)Test notes. The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides nontarget organisms and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.

1. Required for the EP when any end-use formulation may contain other ingredients that may be toxic to nontarget organisms or to support arthropod pheromones that would be available to avian wildlife, (e.g., a granular product).

2. Not required for any use groups if the pesticide is highly volatile (estimated volatility >5 × 10−5atm m 3/mol).

3. Preferred test species are: upland game, waterfowl, or passerine for avian acute oral toxicity studies; upland game or waterfowl for avian dietary studies; and coldwater fish for acute freshwater fish studies.

4. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 7 - AGRICULTURE

§ 136 - Definitions

§ 136a - Registration of pesticides

7 U.S. Code § 136a–1 - Reregistration of registered pesticides

§ 136b - Transferred

§ 136c - Experimental use permits

§ 136d - Administrative review; suspension

§ 136e - Registration of establishments

§ 136f - Books and records

§ 136g - Inspection of establishments, etc.

§ 136h - Protection of trade secrets and other information

§ 136i - Use of restricted use pesticides; applicators

7 U.S. Code § 136i–1 - Pesticide recordkeeping

7 U.S. Code § 136i–2 - Collection of pesticide use information

§ 136j - Unlawful acts

§ 136k - Stop sale, use, removal, and seizure

§ 136l - Penalties

§ 136m - Indemnities

§ 136n - Administrative procedure; judicial review

§ 136o - Imports and exports

§ 136p - Exemption of Federal and State agencies

§ 136q - Storage, disposal, transportation, and recall

§ 136r - Research and monitoring

7 U.S. Code § 136r–1 - Integrated Pest Management

§ 136s - Solicitation of comments; notice of public hearings

§ 136t - Delegation and cooperation

§ 136u - State cooperation, aid, and training

§ 136v - Authority of States

§ 136w - Authority of Administrator

7 U.S. Code § 136w–1 - State primary enforcement responsibility

7 U.S. Code § 136w–2 - Failure by the State to assure enforcement of State pesticide use regulations

7 U.S. Code § 136w–3 - Identification of pests; cooperation with Department of Agriculture’s program

7 U.S. Code § 136w–4 - Omitted

7 U.S. Code § 136w–5 - Minimum requirements for training of maintenance applicators and service technicians

7 U.S. Code § 136w–6 - Environmental Protection Agency minor use program

7 U.S. Code § 136w–7 - Department of Agriculture minor use program

7 U.S. Code § 136w–8 - Pesticide registration service fees

§ 136x - Severability

§ 136y - Authorization of appropriations

U.S. Code: Title 21 - FOOD AND DRUGS