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Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Rules and Regulations
described above for the acute assessment.
iii. Cancer. Based on the data cited in Unit III.A., EPA has concluded that tolfenpyrad does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated PCT information. Section 408b2E of FFDCA authorizes EPA
to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information to establish the tolerance, EPA must require pursuant to FFDCA section 408f1 that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the residue levels in food are not above the levels anticipated. For the present action, EPA
will issue such data call-ins as are required by FFDCA section 408b2E
and authorized under FFDCA section 408f1. Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
Section 408b2F of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food consumption in a particular area, and the exposure estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408b2F, EPA may require registrants to submit data on PCT.
The acute assessment assumes 100
PCT. The Agency incorporated estimates of average PCT in the chronic assessment for the following crops:
Grapefruit 15%, grapes 2.5%, lettuce 10%, onion 2.5%, oranges 5%, peppers less than 2.5%, potatoes 2.5%, tangerines 2.5%, and tomatoes 2.5%.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service USDA/NASS, proprietary market surveys, and California Department of Pesticide
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Regulation CalDPR Pesticide Use Reporting PUR for the chemical/crop combination for the most recent 10
years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%.
In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.
The Agency believes that the three conditions discussed in Unit III.C.1.iv.
have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPAs computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPAs risk assessment process ensures that EPAs exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which tolfenpyrad may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for tolfenpyrad in drinking water. These simulation models take into account data on the physical, chemical, and fate/
transport characteristics of tolfenpyrad.
Further information regarding EPA
drinking water models used in pesticide
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exposure assessment can be found at http www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Residues of tolfenpyrad in surface and ground water were modeled with the Pesticide in Water Calculator PWC
Version 1.52. Groundwater estimated drinking water concentrations were modeled with the Pesticide Root Zone Model Groundwater PRZM GW model within the Pesticide in Water Calculator Version 1.52. For tolfenpyrad, the assessment uses the total residues approach, which is commonly used to assess chemicals that have residues of concern with similar toxicity to parent compound. The recommended estimated drinking water concentrations EDWCs for tolfenpyrad acute exposures are estimated to be 32.6 parts per billion ppb for surface water and 168 ppb for ground water. For chronic exposures for non-cancer assessments, EDWCs are estimated to be 14.1 ppb for surface water and 125 ppb for ground water. For the acute dietary exposure assessment, EPA used an EDWC of 168
ppm. For the chronic dietary exposure assessment, EPA used a value of 125
ppb.
3. From non-dietary exposure. The term residential exposure is used in this document to refer to nonoccupational, non-dietary exposure e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets.
Tolfenpyrad is not registered for any specific use patterns that would result in residential exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide.
4. Cumulative effects from substances with a common mechanism of toxicity.
Section 408b2Dv of FFDCA
requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity.
Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to tolfenpyrad and any other substances, and tolfenpyrad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not
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