(a) Subpart B of this part and Sec. 158.2201 describe how to use the table in paragraph (f) of this section to determine the nontarget plant protection data requirements for a particular antimicrobial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (g) of this section.
(b) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation products or leachate residues meet one of the following criteria:
(1) More toxic, persistent, or bioaccumulative than the parent;
(2) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or
(3) The moiety of concern (i.e., functional group in the parent chemical molecule that imparts adverse effects) remains intact.
(c) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns:
(1) Agricultural premises and equipment.
(2) Food-handling/storage establishments, premises, and equipment.
(3) Commercial, institutional and industrial premises and equipment.
(4) Residential and public access premises.
(5) Medical premises and equipment.
(6) Human drinking water systems.
(7) Materials preservatives.
(8) Swimming pools.
(d) If an antimicrobial may be applied to a field crop, horticultural crop, or turf, then the data requirements in Sec. 158.660 apply.
(e) Key. MP = Manufacturing use product; EP = End-use product; R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
(f) Nontarget plant protection data requirements table. The following table shows the data requirements for nontarget plant protection. The test notes appear in paragraph (g) of this section.
Table--Nontarget Plant Protection Data Requirements------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use pattern Test substance
-------------------------------------------------------------------------------------------------------------------------------------------
Guideline No. Data requirement Industrial Test note No.
processes and water Antifoulant Wood preservatives Aquatic areas All other use MP EP
systems coatings and paints patterns category------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------850.4225......... Seedling CR................. CR................. CR................. CR................. CR................. TEP............ TEP............ 1, 2
emergence, Tier
II--dose response.850.4250......... Vegetative vigor, CR................. NR................. CR................. CR................. CR................. TEP............ TEP............ 1, 3
Tier II--dose
response.850.4400......... Aquatic plant R.................. R.................. R.................. R.................. CR................. TGAI, TEP...... TGAI, TEP...... 4, 10
growth (aquatic
vascular plant)
Tier II--dose
response.850.5400......... Aquatic plant R.................. R.................. R.................. R.................. R.................. TGAI, TEP...... TGAI, TEP...... 4, 5, 6
growth (algal)
Tier II (dose
response).850.4300......... Terrestrial field. CR................. CR................. CR................. CR................. CR................. TEP............ TEP............ 7, 8, 9850.4450......... Aquatic field..... CR................. CR................. CR................. CR................. CR................. TEP............ TEP............ 7, 8, 9------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(g) Test notes. The following test notes apply to the data requirements in the table to paragraph (f) of this section:
1. Data on only one plant species (rice, Oryza sativa) are required.
2. Data are required if the risk quotient from any aquatic plant growth Tier II study exceeds a level of concern for aquatic plants.
3. Not required when:
i. There are no potential exposures to plants;
ii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9; or
iii. The results of a biodegradation study indicate that the active ingredient or principal degradation products are not biodegradable in 28 days, i.e., the biodegradation curve has not reached a plateau for at least three determinations within the 28 days.
4. For TEP testing, data are required for the applicant's end-use product if an ingredient in the end-use product, other than the active ingredient, is expected to enhance the toxicity of the active ingredient.
5. One Tier II (dose response) study, conducted with Selenastrum capricornutum, is required for the all other use patterns category (as specified in Sec. 158.2250(c)). If the results of this study exhibit detrimental effects (EC50 less than 1.0 ppm or mg/L), then additional Tier II (dose response) studies are required on three species (Anabaena flos-aquae, Navicula pelliculosa, and Skeletonema costatum).
6. For industrial processes and water systems, antifoulant coatings and paints, wood preservatives, and aquatic areas, Tier II (dose response) studies are required on four species (Anabaena flos-aquae, Navicula pelliculosa, Skeletonema costatum, and Selenastrum capricornutum).
7. Environmental chemistry methods used to generate data must include the results of a successful confirmatory method trial by an independent laboratory.
8. Tests are required on a case-by-case basis based on the results of lower tier plant protection studies, adverse incident reports, intended use pattern, and environmental fate characteristics that indicate potential exposure.
9. Protocols must be approved by the Agency prior to the initiation of the study.
10. For the all other use patterns category (as specified in Sec. 158.2250(c)), data are required if the aquatic (algal) plant growth Tier II study demonstrates detrimental effects at less than 1.0 ppm or mg/L.