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Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations 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 fluazinam, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to fluazinam and established tolerances for residues of that chemical.
EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological Profile of fluazinam, see Unit III.A. of the April 8, 2016 rulemaking 81 FR 20545 FRL
994299.
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 November 7, 2012 rulemaking 77 FR
66723 FRL93666.
Exposure assessment. Much of the exposure assessment remains the same, although some updates have occurred to accommodate exposures from the petitioned-for tolerances. The updates are discussed in this section.
The acute dietary analysis is based on tolerance-level residues for all commodities and uses high-end residue estimates for the metabolite 3-4-amino3-3-chloro-5- trifloromethyl-2pyridinylamino-2-nitro-6trifluoromethyl phenyl thio-2-betaDglucopyranosyloxy propionic acid, known as AMGT. In addition, the acute assessment assumes 100 percent crop treated PCT and incorporates modeled EDWCs that account for both parent fluazinam and its transformation products. The chronic dietary analysis is based on tolerance level residues for all commodities except apples. For apples, the average field trial value was used. As with the acute assessment, the chronic assessment incorporates highend estimates for AMGT and default processing factors for all relevant processed commodities without a separate tolerance, and modeled EDWCs that account for both parent and transformation products. The chronic assessment also incorporated PCT data.
Anticipated residue and 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
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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 following average PCT estimates were used in the chronic dietary risk assessments for the crops that are currently registered for fluazinam:
Apples <1%, beans 5%, cabbage <1%, carrots <1%, dry beans/peas <2.5%, lima beans 5%, onions <1%, peanuts <2.5%, potatoes 15%, pumpkin <1%, and soybeans <1%.
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 figures for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding up 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
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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 fluazinam may be applied in a particular area.
Dietary exposure from drinking water.
The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for fluazinam 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 FQPA Index Reservoir Screening Tool FIRST and Pesticide Root Zone Model for Groundwater PRZMGW, EPA used an EDWC of 226
ppb for the acute dietary assessment and 141 ppb in the chronic dietary risk assessment.
Non-occupational exposure. See Unit III.C.3. of the April 8, 2016 rulemaking for a discussion of non-dietary exposure, which included residential exposures to golf course turf.
Cumulative exposure. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a
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