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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations
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dockets generally, is available at http
www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance In the Federal Register of April 15, 2020 85 FR 20910 FRL1000654, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 9E8806 by IR4, IR4 Project Headquarters, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of benzovindiflupyr N-9dichloromethylene-1,2,3,4-tetrahydro1,4-methanonaphthalen-5-yl-3difluoromethyl-1-methyl-1H-pyrazole4-carboxamide in or on the raw agricultural commodities Blueberry, lowbush at 2 parts per million ppm and Ginseng at 0.3 ppm. That document referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket EPA
HQOPP20200066, http
www.regulations.gov. There were no comments received in response to the notice of filing.
In the Federal Register of February 4, 2020 85 FR 6129 FRL1000317, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 9F8772 by Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC, 27419. The petition requested that 40 CFR part 180
be amended by establishing tolerances for residues of benzovindiflupyr in or on the raw agricultural commodities Beet, sugar, dried pulp at 0.15 ppm;
Beet, sugar, roots at 0.08 ppm; and Beet, sugar, tops at 0.06 ppm. That document referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket EPA
HQOPP20190586, http
www.regulations.gov. One relevant comment was received in response to the notice of filing. EPAs response to this comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA is establishing several tolerances at different levels than were petitioned for and is also modifying a commodity definition. The reason for these changes is explained in Unit IV.D.
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

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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 benzovindiflupyr including exposure resulting from the tolerances established by this action.
EPAs assessment of exposures and risks associated with benzovindiflupyr 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 benzovindiflupyr, in which EPA
concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to benzovindiflupyr 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 benzovindiflupyr, see Unit III.A. of the
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June 22, 2018 rulemaking 83 FR 29033
FRL997794.
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 October 2, 2015 rulemaking 80 FR
59627 FRL993303.
Exposure Assessment. Much of the exposure assessment remains the same, although some updates have occurred to accommodate exposures from the petitioned-for tolerances and reflect changes to the non-dietary, nonoccupational exposure assessment. The 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 June 22, 2018 rulemaking.
EPAs dietary exposure assessments have been updated to include the additional exposure from the new uses of benzovindiflupyr on lowbush blueberry, ginseng, and sugar beet. The assessment used the same assumptions concerning 100 percent crop treated and tolerance-level residues as the June 22, 2018 final rule. Drinking water exposures are not impacted by the new uses, and thus have not changed since the last assessment.
There have been two updates to the residential exposure assessment since the June 22, 2018 final rule. The updated assessment no longer assesses risks to residential handlers, since the label requirements for handlers to wear specific clothing and to use personal protective equipment PPE are presumed to indicate that these products are not intended for homeowner use; thus, there is no residential handler exposure. The consideration of the new turf use does not change previous conclusions about post-application risk exposures.
EPAs conclusions concerning cumulative risk remain unchanged from the June 22, 2018 rulemaking.
Safety Factor for Infants and Children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act FQPA safety factor. See Unit III.D.
of the June 22, 2018 rulemaking for a discussion of the Agencys rationale for that determination.
Aggregate Risks and Determination of Safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose aPAD and the chronic population adjusted dose cPAD.
Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and
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