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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Rules and Regulations
Division 7505P, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 204600001; main telephone number: 703 3057090;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information A. Does this action apply to me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System NAICS codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Crop production NAICS code 111.
Animal production NAICS code 112.
Food manufacturing NAICS code 311.
Pesticide manufacturing NAICS
code 32532.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPAs tolerance regulations at 40 CFR part 180 through the Office of the Federal Registers eCFR site at https www.ecfr.gov/
current/title-40.

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C. How can I file an objection or hearing request?
Under FFDCA section 408g, 21
U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPAHQ
OPP20200424 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 February 4, 2022. 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
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notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPAHQOPP
20200424, by one of the following methods:
Federal eRulemaking Portal:
https 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 https
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https
www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance In the Federal Register of December 21, 2020 85 FR 82998 FRL1001693, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 9E8820 by Nichino America, Inc., 4550 Linden Hill Road, Suite 501, Wilmington, DE 19808.
The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide isoprothiolane, Diisopropyl 1,3dithiolan-2-ylidenemalonate, in or on raw agricultural commodities banana at 1 part per million ppm; rice, bran, at 30 ppm; rice, husked, at 6 ppm; and rice, polished at 1.5 ppm. That document referenced a summary of the petition prepared by Nichino America, Inc., the registrant, which is available in the docket, https www.regulations.gov.
One comment was received on the notice of filing. EPAs response to the comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has revised one commodity definition and is establishing several tolerances at different levels than requested by the registrant. The reasons 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. Neither of these exposures are relevant to this action, however. 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 isoprothiolane.
EPAs assessment of exposures and risks associated with isoprothiolane 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 primary target organ for isoprothiolane is the liver in rats and mice. Consistent decreases in body weight were also observed at the same or lower doses than the liver effects throughout the database. Adverse liver effects included increases in liver enzymes, increased liver weight absolute and relative, hepatocellular hypertrophy, eosinophilic foci of cellular alterations, eosinophilic cytoplasmic inclusions, and spongiosis hepatis in rats. In mice, following chronic dosing, amyloidosis was observed across several organs at the highest-tested dose. There is no evidence of increased qualitative or quantitative susceptibility in the rat and rabbit developmental toxicity studies or the 2-generation rat reproduction study.
There was no evidence of immunotoxicity, or neurotoxicity observed in any species in the submitted toxicity database.

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