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Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Rules and Regulations
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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
OPP20170653 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 May 4, 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
20170653, 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 March 6, 2018 83 FR 9471 FRL997327, EPA
issued a document pursuant to FFDCA
section 408d3, 21 U.S.C. 346ad3, announcing the filing of a pesticide petition PP 7F8623 by Nippon Soda Co., Ltd c/o Nisso America, Inc., 88 Pine
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The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide picarbutrazox, 1,1-Dimethylethyl N-6Z-1-methyl-1H-tetrazol-5-yl phenylmethylene aminooxymethyl-2pyridinylcarbamate, in or on corn, forage at 0.01 parts per million ppm;
corn, grain at 0.01 ppm; corn, stover at 0.01 ppm; corn, sweet, forage at 0.01
ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; crop group 9, cucurbit vegetables at 0.20 ppm, crop subgroup 416A, leafy greens at 10
ppm; popcorn, grain at 0.01 ppm;
soybean, forage at 0.01 ppm; soybean, hay at 0.01 ppm and soybean, seed at 0.01 ppm. That document referenced a summary of the petition prepared by Nippon Soda Co., Ltd c/o Nisso America, the registrant, which is available in the docket, http
www.regulations.gov. Nine comments were received on the notice of filing.
However, they were not germane to this submission.
Based upon review of the data supporting the petition, EPA is establishing, in accordance with section 408d4ai, tolerances that vary in some respects from what the petitioner requested. Also, EPA is not establishing tolerances for Crop Group 9, Cucurbit Vegetables and Crop Subgroup 416A, Leafy Greens, as the petitioner withdrew the request for those tolerances after submitting the petition. The Agencys underlying rationale for those variations are 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. . . .

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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 picarbutrazox including exposure resulting from the tolerances established by this action.
EPAs assessment of exposures and risks associated with picarbutrazox 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 organs for picarbutrazox are the liver and the thyroid gland across species and durations except acute. The rat was the most sensitive species, followed by the mouse and the dog. Both the liver and the thyroid showed increases in organ weights and histopathological changes.
In the liver, changes included hepatocyte hypertrophy, periportal vacuolation, cytoplasmic inclusions, and portal inflammatory cell infiltration. In the thyroid, there were increased incidences of thyroid hypertrophy which corresponded with increased thyroid weights in both parental animals and neonates.
Disruption of thyroid hormones was also observed across the guideline studies, for the short-term and long-term durations in rats alterations in triiodothyronine T3, thyroxine T4, and thyroid stimulating hormone TSH. Thyroid follicular tumors were observed in rats following 2 years of oral exposure. No treatment-related effects were observed in mice following 78
weeks of exposure. There is no evidence of genotoxicity or mutagenicity in the picarbutrazox hazard database.
There is no evidence of increased prenatal susceptibility in rats or rabbits or postnatal susceptibility in rats. There were no adverse fetal or maternal effects in the available developmental toxicity studies in rats or rabbits. Both studies tested up to the limit dose. In the multigeneration reproductive study, adverse thyroid effects were observed in the parental animals and occurred at doses lower than offspring effects. There were no adverse reproductive effects up to the highest dose tested 46/63 mg/kg/
day.

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