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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations III. Aggregate Risk Assessment and Determination of Safety Section 408b2Ai of FFDCA
allows EPA to establish a tolerance the legal limit for a pesticide chemical residue in or on a food only if EPA
determines that the tolerance is safe.
Section 408b2Aii of FFDCA
defines safe to mean that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408b2C of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .
Consistent with FFDCA section 408b2D, and the factors specified in FFDCA section 408b2D, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for quizalofop ethyl including exposure resulting from the tolerances established by this action.
EPAs assessment of exposures and risks associated with quizalofop ethyl follows.
In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings and republishing the same sections is unnecessary. EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.
EPA has previously published a number of tolerance rulemakings for quizalofop ethyl, in which EPA
concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to quizalofop ethyl and established tolerances for residues of that chemical. EPA is incorporating previously published
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sections from those rulemakings as described further in this rulemaking, as they remain unchanged.
Toxicological Profile. For a discussion of the Toxicological Profile of quizalofop ethyl, see Unit III.A. of the February 23, 2018 rulemaking 83 FR
8006 FRL997230.
Toxicological Points of Departure/
Levels of Concern. For a summary of the Toxicological Points of Departure/
Levels of Concern used for the safety assessment, see Unit III.B. of the December 1, 2016 rulemaking 81 FR
86581 FRL995089.
Exposure Assessment. Much of the exposure assessment remains the same, although updates have occurred to accommodate exposures from the petitioned-for tolerances. These updates are discussed in this section; for a description of the rest of the EPA
approach to and assumptions for the exposure assessment, see Unit III.C. of the February 23, 2018 rulemaking.
EPAs dietary exposure assessments have been updated to include the additional exposure from the new uses of quizalofop ethyl on brassica carinata;
fruit, pome, group 1110; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 1307F; fruit, stone, group 12
12; and pennycress and the crop subgroup expansions for cottonseed subgroup 20C and sunflower subgroup 20B. The assessment used the same assumptions as the February 23, 2018
final rule concerning tolerance level residues and default processing factors for all processed commodities except sunflower oil, where an empirical factor was used.
Updated average percent crop treated values were used for the following crops that are currently registered for quizalofop-ethyl: Beans, green: 2.5%;
canola: 5%; cotton: 1%; dry beans/peas:
15%; peas, green: 2.5%; soybeans: 2.5%;
sugar beets: 1%; and sunflowers: 5%;
and 100% crop treated for other registered and new uses of quizalofop ethyl.
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
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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.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service USDA/NASS, proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 to 7 years. EPA uses an average PCT for chronic 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 one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that Conditions a, b, and c discussed above 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 quizalofop-ethyl may be applied in a particular area.
Drinking water, non-occupational, and cumulative exposures. Drinking
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