40 CFR 158.660 - Nontarget plant protection data requirements table.
(a)General. Sections 158.100 through158.130 describe how to use this table to determine the nontarget plant data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
(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 only the general use patterns of aquatic food crops and aquatic nonfood.
(2) Data are also required for the general use patterns of forestry use and residential outdoor use.
(c)Key. R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
(d)Table. The following table shows the nontarget plant protection data requirements. The table notes are shown in paragraph (e) of this section.
Table - Nontarget Plant Protection Data Requirements
|Guideline Number||Data Requirement||Use Pattern||Test substance||Test Note No.|
|Terrestrial||Aquatic||Forestry and Residential Outdoor|
|Nontarget Area Phytotoxicity - Tier I|
|850.4100||Seedling emergence||R||R||R||TEP||1, 2, 7|
|850.4150||Vegetative vigor||R||R||R||TEP||1, 2, 3, 7|
|Aquatic plant growth (algal and aquatic vascular plant toxicity)||R||R||R||TEP or TGAI||1, 2, 7|
|Nontarget Area Phytotoxicity - Tier II|
|850.4100||Seedling emergence||CR||CR||CR||TEP||1, 4, 5, 7|
|850.4150||Vegetative vigor||CR||CR||CR||TEP||1, 3, 4, 5, 7|
|Aquatic plant growth (algal and aquatic vascular plant toxicity)||CR||CR||CR||TEP or TGAI||1, 4, 6, 7|
|Nontarget Area Phytotoxicity - Tier III|
|850.4300||Terrestrial field||CR||CR||CR||TEP||1, 7, 8, 10|
|850.4450||Aquatic field||CR||CR||CR||TEP||1, 7, 8, 10|
|Target Area Phytotoxicity|
|850.4025||Target area phytotoxicity||CR||CR||CR||TEP||1, 7, 9, 10|
(e)Test notes. The following test notes apply to the table in paragraph (d) of this section.
2. Not required for known phytotoxicants.
3. Generally not required for granular formulations. May be requested on a case-by-case basis.
4. Required for known phytotoxicants such as herbicides, desiccants and defoliants.
5. Required if a tested terrestrial species exhibits a 25 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the Tier I testing.
6. Required if the tested aquatic species exhibits a 50 percent or greater detrimental effect in the Tier I study. When Tier II testing is required, the test species should be the species that showed detrimental effects in the tier I testing.
7. Not required for aquatic residential uses.
8. Environmental chemistry methods used to generate data must include the results of a successful confirmatory method trial by an independent laboratory.
9. Tests are required on a case-by-case basis based on the results of lower tier phytotoxicity studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.
10. Registrants must consult with the Agency on appropriate test protocols prior to designing the study.