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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations and the telephone number for the OPP
Docket is 703 3055805.
Due to the public health concerns related to COVID19, the EPA Docket Center EPA/DC and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC
services and docket access, visit https
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration 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 Government Publishing Offices e-CFR site at http www.ecfr.gov/cgibin/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.

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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
OPP20190230 in the subject line on the first page of your submission. All objections and requests for a hearing
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must be in writing, and must be received by the Hearing Clerk on or before April 12, 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
20190230, 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 August 2, 2019 84 FR 37818 FRL999678, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 9F8747 by Valent U.S.A. LLC, P.O. Box 8025, Walnut Creek, CA 945968025. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the fungicide, ethaboxam, N-cyano-2-thienylmethyl-4-ethyl-2ethylamino-5-thiazolecarboxamide, in or on beet, sugar, root at 0.01 parts per million ppm. That document referenced a summary of the petition prepared by Valent U.S.A. LLC, 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 petition, EPA has modified the commodity definitions, tolerance levels, and tolerances being established. The
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reasons for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety Section 408b2Ai of the 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 the 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 ethaboxam including exposure resulting from the tolerance established by this action.
EPAs assessment of exposures and risks associated with ethaboxam follows.
On August 8, 2017, EPA published in the Federal Register a final rule establishing tolerances for residues of ethaboxam in or on several commodities based on the Agencys conclusion that aggregate exposure to ethaboxam is safe for the general population, including infants and children. See 82 FR 36086
FRL996169. EPA is incorporating the following portions of that document by reference here, as they have not changed in the Agencys current assessment of ethaboxam tolerances:
The toxicological profile and points of departure; description of the assumptions for assessing exposure from residues in or on food, in drinking water, and residential exposures; cancer assessment and conclusion that a nonlinear reference dose Rfd approach is appropriate for assessing cancer risk;
conclusions about cumulative risk;
Agencys determination regarding the childrens safety factor; and tolerance expression, which have not changed.
EPAs risk assessment, titled
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