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Appendix A: Selected Excerpts from 40 CFR Part 158 Data Requirements for Pesticides
Pages 155-170

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From page 155...
... a) FIFRA provides EPA flexibility to require, or not require, data and information for the purposes of making regulatory judgments for pesticide products.
From page 156...
... b) The Agency cautions applicants that the data routinely required in this part may not be sufficient to permit EPA to evaluate the potential of the product to cause unreasonable adverse effects to man or the environment.
From page 157...
... The data routinely required by this part may not be sufficient to permit EPA to evaluate every pesticide product. If the information required under this part is not sufficient to evaluate the potential of the product to cause unreasonable adverse effects on man or the environment, additional data requirements will be imposed.
From page 158...
... The short-term acute and subchronic laboratory studies provide basic toxicity information which serves as a starting point for the hazard assessment. These data are used: To establish acute toxicity levels of the active ingredient to the test organisms; to compare toxicity information with measured or estimated pesticide residues in the environment in order to assess potential impacts on fish, wildlife and other nontarget organisms; and to indicate whether further labora tory and/or field studies are needed.
From page 159...
... General. The data generated by environmental fate studies are used to: Assess the toxicity to man through exposure of humans to pesticide residues remaining after application, either upon reentering treated areas or from consuming inadvertantly-contaminated food; assess the presence of widely distributed and persistent pesticides in the environment which may result in loss of usable land, surface water, ground water, and wild life resources; and, assess the potential environmental exposure of other nontarget organisms, such as fish and wildlife, to pesticides.
From page 160...
... The aquatic use pattern includes products clas sified under the general use patterns of aquatic food crop and aquatic nonfood use patterns. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop.
From page 161...
... The following test notes apply to terrestrial and aquatic nontarget organisms data requirements in the table to paragraph (d) of this section: (1)
From page 162...
... 850.1350 Aquatic invertebrate life CR CR CR CR NR NR TGAI 12, 14, 15 cycle (saltwater) 850.1400 Fish early-life stage R R R R NR NR TGAI 1, 12, 13 (freshwater)
From page 163...
... 850.1710 Aquatic organisms CR CR CR CR NR NR TGAI, PAI, 19 850.1730 bioavailability, degradate 850.1850 biomagnification, toxicity 850.1950 Simulated or actual CR CR CR CR NR NR TEP 7, 20 field testing for aquatic organisms Sediment Testing 850.1735 Whole sediment: acute CR CR CR CR NR NR TGAI 21 freshwater invertebrates 850.1740 Whole sediment: acute CR CR CR CR NR NR TGAI 21, 23 marine invertebrates Whole sediment: chronic CR CR CR CR NR NR TGAI 22, 23 invertebrates freshwater and marine Insect Pollinator Testing 850.3020 Honeybee acute contact R CR R R NR NR TGAI 1 toxicity 850.3030 Honey bee toxicity of CR CR CR CR NR NR TEP 24 residues on foliage 850.3040 Field testing for pollinators CR CR CR CR NR NR TEP 25 163
From page 164...
... iii. An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredi ent or to cause toxicity to aquatic organisms.
From page 165...
... (20) Data are required based on the results of lower tier studies such as acute and chronic aquatic organism testing, intended use pattern, and environmental fate characteristics that indicate significant potential ex posure.
From page 166...
... The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop and terrestrial nonfood crop. The aquatic use pattern includes products classified under the general use patterns of aquatic food crop and aquatic nonfood.
From page 167...
... The following table shows the data requirements for environmental fate. The test notes are shown in paragraph (e)
From page 168...
... , available monitoring data, and the vulnerability of ground water resources in the pesticide use area.
From page 169...
... and mist blower or other methods of ground application are proposed and it is estimated that the detrimental effect level of those nontarget organisms ex pected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants.
From page 170...
... CR R NR NR NR NR TEP 7, 8 835.6300 Forestry NR NR NR NR CR NR TEP 7, 9, 12 835.6400 Combination and tank mixes CR CR NR NR NR NR TEP 10 Ground Water Monitoring 835.7100 Ground water monitoring CR NR NR NR CR CR TEP 7, 9, 11


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