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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Rules and Regulations 20200334, 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.

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II. Summary of Petitioned-For Tolerance In the Federal Register of April 22, 2021 86 FR 21317 FRL1002259, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 9E8798 by Syngenta Crop Protection, LLC, 410
Swing Road, NC 274198300. The petition requested that 40 CFR 180.516
be amended by establishing a tolerance for residues of the fungicide fludioxonil, 4-2,2-difluoro-1,3-benzodioxol-4-yl1H-pyrrole-3-carbonitrile, in or on banana at 2.0 parts per million ppm.
That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http
www.regulations.gov. There were no comments received in response to the notice of filing.
FFDCA section 408d4Ai permits the Agency to finalize a tolerance that varies from that sought by the petition.
Based upon review of the data supporting the petition, EPA is modifying the requested tolerance based on crop field trial data and for consistency with the Organization for Economic Co-Operation and Development OECD tolerancerounding class practice. The reason for these changes are 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
determines that the tolerance is safe.
Section 408b2Aii of FFDCA

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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 therein, 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 fludioxonil, including exposure resulting from the tolerance established by this action.
EPAs assessment of exposures and risks associated with fludioxonil follows.
In an effort to streamline Federal Register publications, EPA is not reprinting here summaries of its analyses that have previously appeared in the Federal Register in previous tolerance rulemakings for the same pesticide. To that end, this rulemaking refers the reader to several sections from the November 6, 2018 tolerance rulemaking for residues of fludioxonil that remain unchanged for an understanding of the Agencys rationale in support of this rulemaking. See 83 FR
55491 FRL998275. Those sections are: Units III.A. Toxicological Profile;
III.B. Toxicological Points of Departure/
Levels of Concern; III.C. Exposure Assessment, except as explained in the next paragraphs; and III.D. Safety Factor for Infants and Children. Further information about the Agencys risk assessment and determination of safety supporting the new tolerance for residues of fludioxonil on bananas can be found in docket ID number EPA
HQOPP20200334 in the document titled Fludioxonil. Human Health Risk Assessment for the Establishment of a Permanent Tolerance on Imported Bananas.
Updates to exposure assessments.
EPAs dietary food and drinking water exposure assessments have been updated to include the additional exposure from use of fludioxonil on bananas, and relied on tolerance-level residues, an assumption of 100 percent crop treated PCT, and 2018 default
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processing factors for all processed commodities. EPAs aggregate exposure assessment incorporated this additional dietary exposure. Drinking water exposures are not impacted by the new use on banana, and thus have not changed since the last assessment.
Assessment of aggregate risks. An acute aggregate risk assessment was not conducted since effects attributable to a single exposure were not identified.
Short-term aggregate risk for adults and children resulted in margins of exposure 280, which is above the level of concern of 100 and not of concern. An intermediate-term aggregate risk assessment was not conducted since exposures are not expected based on the use pattern. The chronic aggregate risk assessment was equivalent to the chronic dietary risk assessment and was not conducted since there are no longterm exposures expected based on the use pattern. Chronic aggregate risks consist of dietary food and drinking water exposure only and are below the Agencys level of concern: 56% of the chronic population adjusted dose cPAD for children 1 to 2 years old, the group with the highest exposure.
Determination of safety. Therefore, based on the risk assessments and information described above, EPA
concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fludioxonil residues. More detailed information on the subject action to establish a tolerance in or on bananas can be found in the document entitled, Fludioxonil.
Human Health Risk Assessment for the Establishment of a Permanent Tolerance on Imported Bananas by going to http www.regulations.gov. The referenced document is available in the docket established by this action, EPA
HQOPP20200334.
IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology high-performance liquid chromatography/ultraviolet HPLC/UV
methods Methods AG597 and AG
597B is available for enforcing tolerances for fludioxonil on plant commodities. An adequate liquid chromatography, tandem mass spectrometry LCMS/MS method Analytical Method GRM025.03A is available for enforcing tolerances for fludioxonil on livestock commodities.
The methods may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 207555350;
telephone number: 410 3052905;

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