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Federal Register / Vol. 86, No. 228 / Wednesday, December 1, 2021 / Rules and Regulations
lotter on DSK11XQN23PROD with RULES1

ppm; and turnip, greens at 3.5 ppm.
Finally, the petition requested upon approval of the above tolerances, to remove the existing time-limited tolerances in 40 CFR 180.442b in or on, apple at 0.5 ppm; nectarine at 0.5
ppm; and peach at 0.5 ppm. That document referenced a summary of the petition prepared by FMC Corporation and Makhteshim Agan of North America, Inc. ADAMA, the registrants, which is available in the docket, http
www.regulations.gov. There were no comments received in response to the notice of filing.
In the Federal Register of February 11, 2020 85 FR 7708 FRL1000502, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 8F8704 by FMC
Corporation, 2929 Walnut Street, Philadelphia, PA 19104. The petition requested that 40 CFR 180.442 be amended by establishing tolerances for residues of the bifenthrin, 2-methyl 1,1-biphenyl-3-yl methyl-3-2-chloro3,3,3,-trifluoro-1-propenyl-2,2
dimethylcyclopropanecarboxylate, in or on sunflower crop subgroup 20B at 0.01 ppm. That document referenced a summary of the petition prepared by FMC Corporation, the registrant, which is available in the docket, http
www.regulations.gov. There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petitions, EPA is establishing some tolerances that vary from what was requested. The reasons for these changes are explained in Unit IV.C.
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
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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 bifenthrin including exposure resulting from the tolerances established by this action.
EPAs assessment of exposures and risks associated with bifenthrin follows.
A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The predominant effects seen in most of the bifenthrin experimental toxicology studies were behavioral changes characteristic of Type I
pyrethroids, such as muscle tremors, which are consistent with its mode-ofaction MOA to activate sodium channels. Additional effects seen in one or more studies included: muscle twitching, decreased grip strength, altered landing foot splay, depressed respiration, increased grooming counts, loss of muscle coordination, staggered gait, exaggerated hind limb flexion, and convulsions at high doses. Decreased body weight and food consumption were also noted in repeat-dosing dietary studies.
In developmental toxicity studies involving rats and rabbits, maternal toxicity was observed neurological effects while no developmental effects of biological significance were observed.
In the 2-generation reproduction dietary study in the rat, tremors were noted only in females of both generations, with one parental generation rat observed to have clonic convulsions, and no observed effects in the offspring.
A developmental neurotoxicity study was also conducted. Clinical signs of neurotoxicity were observed in both the adults and offspring at the same dose levels; therefore, there is no indication of increased qualitative or quantitative susceptibility in the young.
Bifenthrin is classified as a Group C
possible human carcinogen, based on an increased incidence of urinary bladder tumors in mice. However, EPA
has determined that quantification of risk using a non-linear approach i.e.,
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reference dose RfD will adequately account for all chronic toxicity, including potential carcinogenicity, that could result from exposure to bifenthrin for the following reasons. First, the bladder tumors may not be uncommon in mice and are not likely to be malignant. Second, these tumors were observed only in male mice at the highest dose. Third, no evidence of carcinogenicity was observed in bifenthrin carcinogenicity studies in rats. Finally, there is a low concern for mutagenicity based on the overall results of the available mutagenicity tests of bifenthrin.
A complete discussion of the toxicological profile for bifenthrin and the Agencys cancer conclusion as well as specific information on the studies received and the nature of the adverse effects caused by bifenthrin as well as the no-observed-adverse-effect-level NOAEL and the lowest-observedadverse-effect-level LOAEL from the toxicity studies can be found in the documents titled Bifenthrin: Revised Human Health Risk Assessment for the Requested Section 3 Registration of Bifenthrin on Pome Fruit Group 1110
except Mayhaw, Peach Subgroup 12
12B, Avocado, Pomegranate, Brassica Leafy Greens Subgroup 416B; and Crop Group Conversions/Expansions for Tomato Subgroup 810A, Pepper/
Eggplant Subgroup 810B, Small Vine Climbing Fruit Subgroup 1307F, Low Growing Berry Subgroup 1307G, Citrus Fruit Group 10 to Citrus Fruit Group 1010, Caneberry Subgroup 13A to Caneberry Subgroup 1307A, and Tree Nut Group 14 to Tree Nut Group 1412
hereinafter Bifenthrin Multiple Crop Human Health Risk Assessment and Bifenthrin. Human Health Risk Assessment for the Proposed New Use on Sunflower Crop Subgroup 20B in docket ID number EPAHQOPP2016
0352 in regulations.gov.
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/

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