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Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations document titled Pyraclostrobin;
Human Health Risk Assessment for a New Use on Pomegranate hereinafter Pyraclostrobin Human Health Risk Assessment in docket ID number EPAHQOPP20200227.
B. Toxicological Points of Departure/
Levels of Concern Once a pesticides toxicological profile is determined, EPA identifies toxicological points of departure POD
and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment.
PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed the NOAEL and the lowest dose at which adverse effects of concern are identified the LOAEL. Uncertainty/
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-pesticide.
A summary of the toxicological endpoints for pyraclostrobin used for human risk assessment can be found on pages 1011 in the Pyraclostrobin Human Health Risk Assessment.
C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyraclostrobin, EPA
considered exposure under the petitioned-for tolerances as well as all existing pyraclostrobin tolerances in 40
CFR 180.582. EPA assessed dietary exposures from pyraclostrobin 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 pyraclostrobin.

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In conducting the acute dietary exposure assessment, EPA used the 20032008 food consumption data from the U.S. Department of Agricultures National Health and Nutrition Examination Survey, What We Eat in America NHANES/WWEIA. A
partially refined acute dietary exposure assessment was conducted for pyraclostrobin. The analysis used tolerance-level residues or highest average field trial residues HAFT and 100 percent crop treated PCT.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the 20032008
food consumption data from the USDAs NHANES/WWEIA. A partially refined chronic dietary analysis was conducted for pyraclostrobin. The chronic dietary analysis included tolerance-level or average field trial residues and average PCT estimates when available.
iii. Cancer. Pyraclostrobin is classified as Not Likely to Be Carcinogenic to Humans therefore, a cancer assessment is not needed.
iv. Anticipated residue and PCT
information. 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 following average PCT estimates were used in the chronic dietary risk assessments for the crops that are currently registered for pyraclostrobin:
Almonds 45%; apples 20%; apricots 30%; barley 10%; green beans 5%;
blueberries 40%; broccoli 5%; Brussels sprouts 15%; cabbage 10%; caneberries 50%; cantaloupes 15%; carrots 35%;
cauliflower 5%; celery 2.5%; cherries 55%; chicory 5%; corn 10%; cotton seed treatment 10%; cucumber 5%;
dry beans/peas 10%; garlic 10%;
grapefruit 35%; grapes 30%; hazelnuts 20%; lemons 5%; lettuce 5%; nectarines 15%; oats 5%; onions 30%; oranges 5%;

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peaches 25%; peanuts 20%; pears 20%;
green peas 5%; pecans 5%; peppers 15%; pistachios 30%; potatoes 20%;
pumpkins 15%; soybeans seed treatment 10%; spinach 5%; squash 15%; strawberries 65%; sugar beets 50%; sugarcane 5%; sweet corn 5%;
tangerines 10%; tomatoes 25%; walnuts 10%; watermelons 25%; wheat 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 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
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