(a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (c) of this section to determine the terrestrial and aquatic nontarget organisms 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 (d) of this section.
(1) Terrestrial and aquatic nontarget organism data are required to support the registration of most end-use and manufacturing-use antimicrobial products.
(2) Data are generally not required to support end-use products of a gas, highly volatile liquid, highly reactive solid, or a highly corrosive material.
(3) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation/degradation products or leachate residues meet one of the following criteria:
(i) More toxic, persistent, or bioaccumulative than the parent;
(ii) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or
(iii) The moiety of concern (i.e., functional group in the parent chemical molecule that imparts adverse effects) remains intact.
(4) If an antimicrobial may be applied to a field crop, horticultural crop, or turf, then the data requirements in § 158.630 apply.
(5) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns:
(i) Agricultural premises and equipment.
(ii) Food-handling/storage establishments, premises, and equipment.
(iii) Commercial, institutional and industrial premises and equipment.
(iv) Residential and public access premises.
(v) Medical premises and equipment.
(vi) Human drinking water systems.
(vii) Materials preservatives.
(viii) Swimming pools.
(b) 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; PAIRA = Pure active ingredient radiolabeled; a.i. = active ingredient.
(c) Antimicrobial nontarget organism data requirements table. The following table shows the data requirements for nontarget organisms. The test notes appear in paragraph (d) of this section.
Table - Antimicrobial Nontarget Organism Data Requirements
| Guideline No. | Data requirement |
Use pattern | Test substance | Test note No. | |||||
|---|---|---|---|---|---|---|---|---|---|
| Industrial processes and water systems |
Antifoulant coatings and paints | Wood preservatives |
Aquatic areas | All other use patterns category |
MP | EP | |||
| Tier One Testing | |||||||||
| 850.2100 | Acute avian oral toxicity | R | R | R | R | R | TGAI | TGAI | 1 |
| 850.1010 | Acute freshwater invertebrates toxicity | R | R | R | R | R | TGAI | TGAI | 2 |
| 850.1075 | Acute freshwater fish toxicity | R | R | R | R | R | TGAI | TGAI | 3 |
| Higher Tier Testing | |||||||||
| Avian Testing | |||||||||
| 850.2200 | Avian dietary toxicity | CR | CR | CR | CR | CR | TGAI | TGAI | 4 |
| 850.2300 | Avian reproduction | CR | CR | CR | CR | CR | TGAI | TGAI | 1, 6 |
| Aquatic Organisms Testing | |||||||||
| 850.1010 | Acute freshwater invertebrates toxicity | CR | CR | CR | CR | CR | TEP | 2, 5, 7 | |
| 850.1075 | Acute freshwater fish toxicity | CR | CR | CR | CR | CR | TEP | 3, 5, 7 | |
| 850.1025 | Acute estuarine and marine organisms toxicity | CR | R | CR | CR | CR | TGAI | TGAI | 8, 9 |
| 850.1035 | |||||||||
| 850.1045 | |||||||||
| 850.1055 | Acute estuarine and marine organisms toxicity | CR | CR | CR | CR | CR | TEP | 5, 7, 8 | |
| 850.1075 | |||||||||
| 850.1400 | Fish early-life stage | R | R | R | R | R | TGAI | TGAI | 10 |
| 850.1300 | Aquatic invertebrate life-cycle | R | R | R | R | R | TGAI | TGAI | 10 |
| 850.1350 | |||||||||
| 850.1500 | Fish life-cycle | CR | CR | CR | CR | CR | TGAI | TGAI | 11, 12 |
| 850.1710 | Aquatic organisms, bioavailability, biomagnification, toxicity tests | CR | CR | CR | CR | CR | TGAI, PAI, degradate | TGAI, PAI, degradate | 13 |
| 850.1730 | |||||||||
| 850.1850 | |||||||||
| 850.1950 | Simulated or actual field testing for aquatic organisms | CR | CR | CR | CR | CR | TEP | TEP | 14, 15, 16 |
| Sediment Testing | |||||||||
| 850.1735 | Whole sediment; acute freshwater invertebrates | CR | CR | CR | CR | CR | TGAI | TGAI | 15, 17 |
| 850.1740 | Whole sediment; acute marine invertebrates | CR | CR | CR | CR | CR | TGAI | TGAI | 15, 17, 19 |
| None | Whole sediment; chronic invertebrates fresh-water and marine | CR | CR | CR | CR | CR | TGAI | TGAI | 15, 18, 19 |
| Insect Pollinator Testing | |||||||||
| 850.3020 | Honeybee acute contact | NR | NR | R | NR | CR | TGAI | TGAI | 20 |
| 850.3030 | Toxicity of residues to honeybees | NR | NR | R | NR | CR | TGAI | TEP or treated wood | 20, 21 |
(d) Test notes. The following test notes apply to the data requirements in the table to paragraph (c) of this section:
1. For industrial processes and water systems, antifoulant paints and coatings, wood preservatives, and aquatic areas, data are required for two avian species: one waterfowl species and one upland game bird species. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required for one avian species.
2. Data are required on one freshwater aquatic invertebrate species.
3. For the industrial processes and water systems, antifoulant paints and coatings, wood preservatives, and aquatic use pattern areas, data are required on two species of fish, one cold water species and one warm water species. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required on one species of fish, either one cold water species or one warm water species. Testing on a second species is required if the active ingredient or principal transformation products are stable in the environment and the LC50 in the first species is less than or equal to 1 ppm or 1 mg/L.
4. Data are required on one avian species, either one waterfowl species or one upland game bird species, if the avian acute oral LD50 (TGAI testing) is less than or equal to 100 mg/a.i./kg and a.i. residues or its principal transformation products are likely to occur in avian feed items. Data on the second species are required if the avian dietary LC50 in the first species tested is less than or equal to 500 ppm a.i. in the diet.
5. If TEP testing cannot be conducted due to the physical characteristics of the test substance (for example, a paint), then the applicant should request a waiver.
6. Data are required if one or more of the following criteria are met:
i. Birds may be subjected to repeated or continued exposure to the pesticide or any of its transformation products, especially preceding or during the breeding season.
ii. The pesticide or any of its major metabolites or degradation products are stable in the environment to the extent that a potentially toxic amount may persist in avian feed.
iii. The pesticide or any of its major metabolites or degradation products are stored or accumulated in plant or animal tissues, as indicated by the octanol/water partition coefficient (Kow is greater than or equal to 1,000), accumulation studies, metabolic release and retention studies, or as indicated by structural similarity to known bioaccumulative chemicals.
iv. Any other information, such as that derived from mammalian reproduction studies, indicates that reproduction in terrestrial vertebrates may be adversely affected by the anticipated use of the pesticide product.
7. TEP testing is required for any product which meets one or more of the following conditions:
i. When based on deterministic modeling results: If the Estimated Environmental Concentration (EEC) in the aquatic environment is equal to or greater than one-half the LC50/EC50 of the TGAI.
ii. When based on probabilistic modeling results: If the estimated 10th percentile 7Q10 Surface Water Concentration exceeds the acute concentration of concern (i.e., one-half the LC50/EC50).
iii. If an ingredient in the end-use product other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
iv. The end-use antimicrobial product will be applied directly into an aquatic environment.
8. Data are required on one estuarine/marine mollusk, one other estuarine/marine invertebrate, and one estuarine/marine fish species.
9. For the all other use patterns category (as specified in § 158.2240(a)(5)), industrial processes and water systems, wood preservatives, and aquatic areas, data are required if the pesticide residues from the parent compound and/or transformation products are likely to enter the estuarine/marine environment.
10. Testing must be conducted with the most sensitive organism (either freshwater or estuarine/marine vertebrates, or freshwater or estuarine/marine invertebrates), as determined from the results of the acute toxicity tests (acute EC50 freshwater invertebrates; acute LC50/EC50 estuarine and marine organisms; acute freshwater fish LC50).
11. Data are required on estuarine/marine species if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations because of its expected use or mobility patterns.
12. Data are required on freshwater species if the end-use product is intended to be applied directly to water, or is expected to be transported to water from the intended use site, and when one or more of the following conditions apply:
i. When based on deterministic modeling results: If the Estimated Environmental Concentration (EEC) in water is equal to or greater than 0.1 of the no-observed-adverse-effect concentration or no-observed-adverse-effect level (NOAEC/NOAEL) in the fish early-life stage or invertebrate life cycle tests.
ii. When based on probabilistic modeling results: If the estimated 10th percentile 7Q10 Surface Water Concentration based on probabilistic modeling exceeds for 20 days or more the chronic concentration of concern (i.e., one-tenth the NOAEC or NOAEL) determined in the fish early-life stage or invertebrate life cycle tests.
iii. If studies of other organisms indicate that the reproductive physiology of fish may be affected.
13. Not required when:
i. The octanol/water partition coefficients of the pesticide and its major degradates are less than 1,000;
ii. There are no potential exposures to fish and other nontarget aquatic organisms; or
iii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9.
14. Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.
15. Protocols must be approved by the Agency prior to the initiation of the study.
16. Data are required if the intended use pattern, and the physical/chemical properties and environmental fate characteristics of the antimicrobial indicate significant potential exposure, and, based on the results of the acute and chronic aquatic organism testing, significant impairment of nontarget aquatic organisms could result.
17. Data are required if the half-life of the pesticide in the sediment is equal to or less than 10 days in either the aerobic soil or aquatic metabolism studies, and if one or more of the following conditions are met:
i. The soil partition coefficient (Kd) is equal to or greater than 50 L/kg.
ii. The log Kow is equal to or greater than 3.
iii. The Koc is equal to or greater than 1,000.
18. Data are required if the EEC in sediment is greater than 0.1 of the acute LC50/EC50 values and if one or more of the following conditions are met:
i. The soil partition coefficient (Kd) is equal to or greater than 50 L/kg.
ii. The log Kow is equal to or greater than 3.
iii. The Koc is equal to or greater than 1,000.
19. Sediment testing with estuarine/marine test species is required if the product is intended for direct application to the estuarine or marine environment or the product is expected to enter this environment in significant concentrations either by runoff or erosion, because of its expected use or mobility pattern.
20. For the all other use patterns category (as specified in § 158.2240(a)(5)), data are required only for beehive applications when the beehive (empty or occupied) may be treated.
21. A study similar to “Honey Bee Toxicity of Residues on Foliage” is required using treated wood instead of the foliage. Protocols must be approved by the Agency prior to the initiation of the study.