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Title 40Chapter ISubchapter EPart 158 → Subpart N

Title 40: Protection of Environment

Subpart N—Environmental Fate

§158.1300   Environmental fate data requirements table.

§158.1300   Environmental fate data requirements table.

(a) General. All environmental fate data, as described in paragraph (c) of this section, must be submitted to support a request for registration.

(b) Use patterns. (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 the general use patterns of aquatic food crop, and aquatic nonfood. The greenhouse use pattern includes both food and nonfood uses. The indoor use pattern includes food, nonfood, and residential indoor uses.

(2) Data are also required for the general use patterns of forestry use and residential outdoor use.

(c) Key. CR=Conditionally required; NR=Not required; R=Required; PAIRA=Pure active ingredient radio-labeled; TGAI=Technical grade of the active ingredient; TEP=Typical end-use product.

(d) Table. The following table shows the data requirements for environmental fate. The test notes are shown in paragraph (e) of this section.

Table—Environmental Fate Data Requirements

Guideline Number Data Requirement Use Pattern Test substance Test Note No.
Terrestrial Aquatic Greenhouse Indoor Forestry Residential Outdoor
Degradation Studies - Laboratory
835.2120HydrolysisRRRCRRRTGAI or PAIRA1
835.2240Photodegradation in waterRRNRNRRNRTGAI or PAIRA2
835.2410Photodegradation on soilRNRNRNRRNRTGAI or PAIRA3
835.2370Photodegradation in airCRNRCRNRCRCRTGAI or PAIRA4
Metabolism Studies - Laboratory
835.4100Aerobic soilRCRRNRRRTGAI or PAIRA5
835.4200Anaerobic soilRNRNRNRNRNRTGAI or PAIRA--
835.4300Aerobic aquaticRRNRNRRNRTGAI or PAIRA--
835.4400Anaerobic aquaticRRNRNRRNRTGAI or PAIRA--
Mobility Studies
Leaching and adsorption/desorptionRRRNRRRTGAI or PAIRA6
835.1410Volatility - laboratoryCRNRCRNRNRNRTEP4
835.8100Volatility - fieldCRNRCRNRNRNRTEP--
Dissipation Studies - Field
835.6100TerrestrialRCRNRNRCRRTEP5, 7, 12
835.6200Aquatic (sediment)CRRNRNRNRNRTEP7, 8
835.6300ForestryNRNRNRNRCRNRTEP7, 9, 12
835.6400Combination and tank mixesCRCRNRNRNRNRTEP10
Ground Water Monitoring
835.7100Ground water monitoringCRNRNRNRCRCRTEP7, 9, 11

(e) Test notes. The following test notes apply to the requirements in the table to paragraph (d) of this section:

1. Study is required for indoor uses in cases where environmental exposure is likely to occur. Such sites include, but are not limited to, agricultural premises, in or around farm buildings, barnyards, and beehives.

2. Not required when the electronic absorption spectra, measured at pHs 5, 7, and 9, of the chemical and its hydrolytic products, if any, show no absorption or tailing between 290 and 800 nm.

3. Not required when the chemical is to be applied only by soil injection or is incorporated in the soil.

4. Requirement based on use patterns and other pertinent factors including, but not limited to, the Henry's Law Constant of the chemical. In view of methodological difficulties with the study of photodegradation in air, prior consultation with the Agency regarding the protocol is recommended before the test is performed.

5. Required for aquatic food and nonfood crop uses for aquatic sites that are intermittently dry. Such sites include, but are not limited to, cranberry bogs and rice paddies.

6. Adsorption and desorption using a batch equilibrium method is preferred. However in some cases, for example, where the pesticide degrades rapidly, soil column leaching with unaged or aged columns may be more appropriate to fully characterize the potential mobility of the parent compound and major transformation products.

7. 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.

8. Requirement for terrestrial uses is based on potential for aquatic exposure and if pesticide residues have the potential for persistence, mobility, nontarget aquatic toxicity or bioaccumulation. Not required for aquatic residential uses. Field testing under the terrestrial field dissipation requirement may be more appropriate for some aquatic food crops, such as rice and cranberry uses, that are managed to have a dry-land period for production. The registrant is encouraged to consult with the Agency on protocols.

9. Agency approval of a protocol is necessary prior to initiation of the study.

10. This study may be triggered if there is specific evidence that the presence of one pesticide can affect the dissipation characteristics of another pesticide when applied simultaneously or serially.

11. Required if the weight-of-evidence indicates that the pesticide and/or its degradates is likely to leach to ground water, taking into account other factors such as the toxicity of the chemicals(s), available monitoring data, and the vulnerability of ground water resources in the pesticide use area.

12. If the terrestrial dissipation study cannot assess all of the major routes of dissipation, the forestry study will be required.

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