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Federal Register / Vol. 86, No. 228 / Wednesday, December 1, 2021 / Rules and Regulations
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Although the acute dietary exposure estimates are refined, the exposure estimates will not underestimate risk for the established and proposed uses of bifenthrin since the residue levels used are based on either monitoring data reflecting actual residues found in the food supply, or on high-end residues from field trials which reflect the use patterns which would result in highest residues in foods. Furthermore, processing factors used were either those measured in processing studies, or default high-end factors representing the maximum concentration of residue into a processed commodity. EPA made conservative protective assumptions to assess exposure to bifenthrin in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed by bifenthrin.
E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD aPAD and chronic PAD cPAD. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to bifenthrin will occupy 15% of the aPAD
for infants <1 year old, the population group receiving the greatest exposure.
The acute aggregate risk assessment combines exposures to bifenthrin in food and drinking water only and is equivalent to the acute dietary assessment. There are no acute aggregate risks estimates of concern.
2. Chronic risk. The chronic food and drinking water exposure assessment for bifenthrin was conducted solely for the purpose of obtaining an average dietary exposure estimate for use in the aggregate assessment. The population subgroup with the highest average dietary exposure estimate is children 1
to 2 years old 0.000189 mg/kg/day.
3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water considered to be a background
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exposure level. Bifenthrin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to bifenthrin.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 520 for adults treated gardens. The short-term aggregate assessment for children 1 to less than 2
years old resulted in an MOE of 170
treated turf at 0.23 lb ai/A. The shortterm aggregate assessment for children 6
to less than 11 years old and children 11 to 16 years old resulted in MOEs of 1,600 treated gardens and 7,600
golfing, respectively. Because EPAs level of concern for bifenthrin is an MOE of 100 or lower, these MOEs are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water considered to be a background exposure level.
While there is potential intermediateterm residential exposure, because the single dose and repeat dosing bifenthrin studies show that repeat exposures do not result in lower points of departure, the residential assessments are conducted as a series of acute exposures and the same endpoint is used regardless of duration. Therefore, the short-term aggregate assessment is considered protective of any intermediate-term exposures.
5. Aggregate cancer risk for U.S.
population. EPA has concluded that the acute reference dose RfD will adequately account for all repeated exposures, including carcinogenicity, which could result from exposure to bifenthrin.
6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to bifenthrin residues.
IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology gas chromatography with an electron capture detector GC/ECD analyses for determining bifenthrin residues in both plant and livestock commodities is available to enforce the tolerance expression. The method may be
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requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 207555350; telephone number: 410 3052905; email address:
residuemethods@epa.gov.
B. International Residue Limits In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits MRLs established by the Codex Alimentarius Commission Codex, as required by FFDCA section 408b4.
The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA
may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408b4 requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established any MRLs for bifenthrin in or on apple, wet pomace; avocado; fruit, pome, group 1110; peach, or pomegranate. The following U.S. tolerances being established are harmonized with the Codex MRLs, which are identified in parentheses: Caneberry subgroup 13
07A at 1 ppm blackberry, dewberries and raspberries; fruit, citrus, group 10
10 at 0.05 ppm citrus fruit; and nut, tree, group 1412 at 0.05 ppm tree nuts. The U.S. tolerance for pepper/
eggplant subgroup 810B at 0.5 ppm is harmonized with the Codex MRL on pepper. It is not possible to harmonize with the Codex MRLs of all commodities in the subgroup, including eggplant at 0.3 ppm and dried chili peppers at 5 ppm.
The Codex has established an MRL for bifenthrin in or on grape at 0.3 ppm.
The Agency is establishing the tolerance in or on fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 1307F
at 0.3 ppm rather than at 0.2 ppm, the existing U.S. tolerance on grape to harmonize with the Codex MRL on grape.
The Canadian MRL for bifenthrin in or on pear is 0.9 ppm and there are no Codex MRLs for the commodities in the pome fruit crop group. EPA is establishing the U.S. tolerance for fruit, pome, group 1110, except mayhaw at 0.9 ppm rather than at the request level of 0.70 ppm based on submitted residue data and the existing U.S. tolerance for
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