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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations
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.
For the acute assessment, the following PCT assumptions were made:
Cypermethrin The following maximum percent crop treated estimates were used in the acute dietary risk assessment for the following crops that are currently registered for cypermethrin: Lettuce, head: 5%;
lettuce, leaf: 5%; broccoli: 10%;
cabbage: 10%; cauliflower: 10%.

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Zeta-Cypermethrin The following maximum percent crop treated estimates were used in the acute dietary risk assessment for the following crops that are currently registered for zeta-cypermethrin: Lettuce, head: 75%;
lettuce, leaf: 75%; spinach: 55%; celery:
60%; broccoli: 30%; cabbage: 45%;
cauliflower: 25%; bean, green: 20%;
tomato, puree: 20%; orange, juice: 55%;
grapefruit, juice: 65%; peach: 10%;
grape: 5%; rice: 15%; sugarcane: 2.5%.
Alpha-Cypermethrin The following maximum percent crop treated estimates were used in the acute dietary risk assessment for the following crops that are currently registered for cypermethrin: Lettuce, head: 20%;
lettuce, leaf: 20%; spinach: 2.5%;
celery: 2.5%; broccoli: 2.5%; cabbage:
2.5%; cauliflower: 2.5%; bean, green:
2.5%; tomato, puree: 2.5%; orange, juice: 2.5%; grapefruit, juice: 2.5%; rice:
85%.
In the chronic assessment, the Agency made the conservative assumption of
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100% crop treated for all commodities with established tolerances. However, PCT was effectively incorporated into the assessment through the use of monitoring data for some commodities, which reflect the PCT for commodities in commerce. For the FHE uses, EPA
incorporated an estimate of the probability that a food item a person consumes contains residues as a result of treatment in an FHE at some point with any pesticide. This estimate is 4.65%, which is not specific to the cypermethrins. In the chronic assessment, EPA used this value for all commodities that do not have established tolerances. EPA also used this value when the total anticipated residue for a commodity was higher for the FHE use than it was for the agricultural use.
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 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
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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 zeta-cypermethrin 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 zeta-cypermethrin in drinking water.
Further information regarding EPA
drinking water models used in pesticide exposure assessment can be found at http www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Surface Water Concentration Calculator SWCC and the Pesticide Root Zone Model for Groundwater PRZMGW, for the acute dietary risk assessment, EPA used an estimated drinking water concentration EDWC of 3.5 ppb in the DEEMFCID
Model. For the chronic exposure assessment used to determine background exposure from food and drinking water for the purpose of aggregate risk assessment, EPA used a value of 0.035 ppb for both direct and indirect water. The groundwater estimate of 0.0036 ppb was much lower than surface water residues; therefore, the Agency used the surface water EDWCs in the assessments. The use of the surface water values in the dietary exposure assessment is protective of potential exposure through groundwater sources of drinking water.
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. The cypermethrins are registered for a variety of non-agricultural purposes including recreational sites i.e., golf courses, athletic fields; indoor residential/commercial/industrial sites/
structural/perimeter and lawn uses;
gardens and trees; as well as mosquito adulticide, termiticide, and pet uses.
The current action does not add any new uses with residential exposures.
For assessing aggregate exposure to adults, the Agency used exposures from
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