§ 158.2280 Environmental fate.
(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 environmental fate data requirements for antimicrobial pesticide products. Notes that apply to an individual test including specific conditions, qualifications, or exceptions are listed in paragraph (d) of this section.
(1) Environmental fate data are required to support the registrations of all end-use and manufacturing-use antimicrobial products.
(2) 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:
(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.
(3) 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; ROC = residue of concern.
(c) Antimicrobial environmental fate data requirements table. The following table shows the data requirements for environmental fate. The test notes appear in paragraph (d) of this section.
Table—Antimicrobial Environmental Fate 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 | |||
| Degradation Studies—Laboratory | |||||||||
| 835.2120 | Hydrolysis | R | R | R | R | R | TGAI or PAIRA | TGAI or PAIRA | 1 |
| 835.2240 | Photodegradation in water | R | R | R | R | R | TGAI or PAIRA | TGAI or PAIRA | 2 |
| 835.2410 | Photodegradation in soil | NR | NR | R | NR | NR | TGAI or PAIRA | TGAI or PAIRA | 10 |
| Toxicity and Fate in Wastewater Systems | |||||||||
| 850.6800 | Activated Sludge, Respiration Inhibition Test | R | R | R | NR | R | TGAI | TGAI | 21 |
| OECD 209 | |||||||||
| 835.1110 | Activated Sludge Sorption Isotherm | CR | CR | CR | NR | CR | TGAI | TGAI | 19, 20 |
| 835.3110 | Ready Biodegradability | CR | CR | CR | NR | CR | TGAI | TGAI | 3, 4, 18 |
| 835.3220 | Porous Pot Study | CR | CR | CR | NR | CR | TGAI | TGAI | 3, 18 |
| 835.3280 | Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater | CR | CR | CR | NR | CR | TGAI | TGAI | 3, 18 |
| 835.3240 | Simulation Test—Aerobic Sewage Treatment: A. Activated Sludge Units | CR | CR | CR | NR | CR | TGAI | TGAI | 3, 18 |
| Mobility Studies | |||||||||
| 835.1230 | Leaching and adsorption/de-sorption | R | R | R | R | CR | TGAI or PAIRA | TGAI or PAIRA | 5, 6 |
| 835.1240 | |||||||||
| Metabolism Studies—Laboratory | |||||||||
| 835.4100 | Aerobic soil metabolism | CR | NR | R | CR | CR | TGAI or PAIRA | TGAI or PAIRA | 7, 8, 9 |
| 835.4200 | Anaerobic soil metabolism | NR | NR | R | NR | CR | TGAI or PAIRA | TGAI or PAIRA | 5, 8 |
| 835.4300 | Aerobic aquatic metabolism | R | R | R | R | CR | TGAI or PAIRA | TGAI or PAIRA | 5, 8 |
| 835.4400 | Anaerobic aquatic metabolism | R | R | R | R | CR | TGAI or PAIRA | TGAI or PAIRA | 5, 8 |
| Dissipation Studies—Field | |||||||||
| 835.6200 | Aquatic (sediment) | CR | R | CR | R | CR | TEP | TEP | 11, 12, 13 |
| Ground and Surface Water Monitoring | |||||||||
| None | Monitoring of representative U.S. waters | CR | CR | CR | CR | CR | ROC | ROC | 11, 14, 17 |
| Special Studies | |||||||||
| None | Special leaching | NR | R | R | NR | NR | TGAI | TEP | 15, 16 |