Quiero saber acerca de...

Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Rules and Regulations
jbell on DSKJLSW7X2PROD with RULES

provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPAHQ
OPP20200228 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before September 13, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR
178.25b.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing excluding any Confidential Business Information CBI for inclusion in the public docket.
Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPAHQOPP
20200228, by one of the following methods:
Federal eRulemaking Portal: http
www.regulations.gov. Follow the online instructions for submitting comments.
Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center EPA/
DC, 28221T, 1200 Pennsylvania Ave.
NW, Washington, DC 204600001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http www.epa.gov/
dockets.
II. Summary of Petitioned-For Tolerance In the Federal Register of September 30, 2020 85 FR 61681 FRL1001474, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 0E8825 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 EPA establish tolerances in 40 CFR part 180 for residues of fluxapyroxad, BAS 700 F; 3difluoromethyl-1-methyl-N-3,4,5trifluoro1,1-biphenyl-2-yl-1Hpyrazole-4-carboxamide, its metabolites, and degradates in or on the raw agricultural commodities: Pomegranate at 0.2 ppm; vegetable, fruiting, group 8

VerDate Sep<11>2014

15:52 Jul 12, 2021

Jkt 253001

10 at 0.7 ppm; fruit, pome, group 1110
at 0.8 ppm; and cottonseed subgroup 20C at 0.3 ppm. The petition also requested to remove the established tolerances for fluxapyroxad in or on fruit, pome, group 11; vegetables, fruiting, group 8; and cotton, undelinted seed. That document referenced a summary of the petition prepared by BASF, the registrant, which is available in the docket, http
www.regulations.gov. No comments were received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA is establishing one tolerance at a different level than requested. The reason for this change is 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 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 fluxapyroxad including exposure resulting from the tolerances established by this action.
EPAs assessment of exposures and risks associated with fluxapyroxad 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
PO 00000

Frm 00035

Fmt 4700

Sfmt 4700

36667

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 fluxapyroxad, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to fluxapyroxad 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 fluxapyroxad, see Unit III.A. of the May 5, 2016 rulemaking 81 FR 27019 FRL
994548.
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 May 5, 2016 rulemaking.
Exposure Assessment. Much of the exposure assessment remains the same, although updates have occurred to accommodate exposures from the petitioned-for tolerances. The updates are discussed in this section; the remaining discussion of EPAs assumptions for exposure remain unchanged since the 2016 rulemaking.
For a description of the rest of the EPA
approach to and assumptions for the exposure assessment, see Unit III.C. of the May 5, 2016 rulemaking.
EPAs dietary exposure assessments have been updated to include the additional exposure from the new use of fluxapyroxad on pomegranate, and the crop group expansions to the cottonseed subgroup 20C, the fruiting vegetable group 810, and the pome fruit group 1110. A partially refined acute dietary exposure analysis was performed for the general population and all population subgroups. Tolerance-level residues adjusted to account for the metabolite of concern M700F008 and 100 percent crop treated PCT assumptions were used for all plant commodities. For livestock commodities, anticipated residues accounting for parent and the metabolites of concern M700F008 and/
or M700F010 were used. A moderately refined chronic dietary exposure analysis was performed for the general U.S. population and various population subgroups. Average field trial residues for parent plus maximum metabolite
E:FRFM13JYR1.SGM

13JYR1