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Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations
Reading Room, please visit http
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.
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
OPP20200227 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 November 19, 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
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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
20200227, 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 0E8826 by IR4, IR4 Project Headquarters, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition requested to establish tolerances in 40
CFR 180.582 for residues of the sum of pyraclostrobin, carbamic acid, 2-14-chlorophenyl-1H-pyrazol-3yloxymethylphenylmethoxy-, methyl ester and its desmethoxy metabolite methyl-N-1-4-chlorophenyl-1Hpyrazol-3-yloxymethyl phenylcarbamate, calculated as the stoichiometric equivalent of pyraclostrobin, in or on the raw agricultural commodity pomegranate at 0.3 ppm. 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.
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
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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 pyraclostrobin including exposure resulting from the tolerances established by this action.
EPAs assessment of exposures and risks associated with pyraclostrobin 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 tissues following repeated pyraclostrobin exposure appear to be mucosal membranes, with histopathology or secondary effects e.g., diarrhea observed in different species.
The primary effects were decreased body weight and food consumption in addition to diarrhea. There was no observed neurotoxicity, mutagenicity, genotoxicity, or immunotoxicity in the database. Also, there was no evidence of increased susceptibility following prenatal exposure to rats and rabbits in the developmental toxicity studies, nor following preand post-natal exposure to rats in the multi-generation reproduction study. Pyraclostrobin is classified as not likely to be carcinogenic to humans.
Additional information on the toxicological profile can be found at http www.regulations.gov in the
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