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Federal Register / Vol. 86, No. 228 / Wednesday, December 1, 2021 / Rules and Regulations
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safety factors are used in conjunction with the POD to calculate a safe exposure levelgenerally referred to as a population-adjusted dose PAD or a reference dose RfDand a safe margin of exposure MOE. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological endpoints for bifenthrin used for human risk assessment can be found in the Bifenthrin Multiple Crop Human Health Risk Assessment.
C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to bifenthrin, EPA considered exposure under the petitioned-for tolerances as well as all existing bifenthrin tolerances in 40 CFR 180.442.
EPA assessed dietary exposures from bifenthrin in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.
Such effects were identified for bifenthrin. In estimating acute dietary exposure, EPA used 20032008 food consumption data from the United States Department of Agricultures USDAs National Health and Nutrition Examination Survey, What We Eat in America NHANES/WWEIA. As to residue levels in food, the acute assessment was refined using distributions and point estimates derived from pesticide data program PDP monitoring data, field trial data, percent crop treated PCT data, and empirical processing factors.
ii. Chronic exposure. A chronic dietary endpoint has not been selected for bifenthrin because repeated exposure does not result in a POD lower than that resulting from acute exposure;
therefore, the acute dietary risk assessment is protective of chronic dietary risk. However, since there are residential uses of bifenthrin, a refined chronic dietary exposure assessment was conducted to calculate average food and drinking water exposure estimates representing background
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dietary exposure to support the bifenthrin aggregate risk assessment.
The assessment was refined using point estimates derived from PDP monitoring data, field trial data, PCT data, and empirical processing factors.
iii. Cancer. As discussed in Unit III.A., EPA has determined that the acute reference dose RfD will adequately account for all repeated exposure/chronic toxicity, including potential carcinogenicity, which could result from exposure to bifenthrin. A
separate cancer exposure assessment was not conducted.
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, 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 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 dietary assessment used the following maximum PCT estimates:
Almonds: 40%, artichoke: 65%, green beans fresh & succulent: 60%, blueberries all bushberries: 35%, broccoli: 25%, Brussel sprouts: 5%, cabbage: 50%, caneberries: 55%, canola:
25%, cantaloupes: 55%, carrots: 5%, cauliflower: 2.5%, celery: 45%, citrus
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all others: 2.5%, corn: 10%, cotton:
20%, cucumbers: 35%, dry beans/peas:
5%, eggplant: 45%, grapefruit: 2.5%, grapes, juice: 10%, grapes, table: 2.5%, grapes, wine: 5%, hazelnuts: 5%, honeydews: 90%, kumquat: 2.5%, lemons: 2.5%, lettuce; 15%, lima beans:
40%, lime: 2.5%, okra: 45%, onions:
5%, oranges, 10%, peanuts: 20%, pears:
2.5%, green peas fresh & succulent:
50%, pecans: 20%, peppers all; 30%, pistachios: 55%, potatoes: 15%, pummelo: 2.5%, pumpkins: 25%, soybeans: 10%, spinach: 15%, squash:
25%, strawberries: 70%, sweet corn:
50%, tangerines: 2.5%, tomatoes: 45%, walnuts: 25%, and watermelons: 20%.
The acute dietary assessment also used the following maximum PCT estimates for some of the new uses: apples: 55%, avocados: 50%, nectarines: 65%, peaches: 35%, and pomegranates: 60%.
The following average PCT estimates for bifenthrin were used to refine the chronic dietary risk assessment for the following crops: Almonds: 25%, artichoke: 30%, green beans fresh &
succulent: 55%, blueberries all bushberries: 10%, broccoli: 15%, Brussel sprouts: 1%, cabbage: 30%, caneberries: 45%, canola: 10%, cantaloupes: 50%, carrots: 2.5%, cauliflower: 1%, celery: 10%, citrus all others: 1%, corn: 5%, cotton: 15%, cucumbers: 20%, dry beans/peas: 2.5%, eggplant: 25%, grapefruit: 1%, grapes, juice: 2.5%, grapes, table: 1%, grapes, wine: 2.5%, hazelnuts: 1%, honeydews:
25%, kumquat: 1%, lemons: 1%, lettuce; 10%, lima beans: 20%, lime:
1%, okra: 25%, onions: 2.5%, oranges, 1%, peanuts: 10%, pears: 1%, green peas fresh & succulent: 30%, pecans:
10%, peppers all; 20%, pistachios:
35%, potatoes: 10%, pummelo: 1%, pumpkins: 15%, soybeans: 5%, spinach:
2.5%, squash: 20%, strawberries: 55%, sweet corn: 40%, tangerines: 1%, tomatoes: 25%, walnuts: 15%, and watermelons: 15%. The chronic dietary assessment also used the following maximum PCT estimates for some of the new uses: apples: 50%, avocados: 50%, nectarines: 65%, peaches: 35%, and pomegranates: 60%.
A default of 100% CT was used for all livestock and game commodities, freshwater finfish, and all other registered uses where no maximum/
average PCT estimates were available.
All other commodities included for depicting food handling establishment FHE uses were refined with the upper bound estimate of 4.65% for nonfumigant treatments made in FHEs.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service USDA/NASS,
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