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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Rules and Regulations Mail Code 1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
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
20200009, 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 May 29, 2020 85 FR 32338 FRL1000984, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 9E8811 by American Spice Trade Association, 1101 17th Street NW, Suite 700, Washington, DC 20036. The petition requested that 40 CFR 180.408 be amended by establishing tolerances for residues of the fungicide metalaxyl, methyl N-2,6-dimethylphenyl-Nmethoxyacetyl-DL-alaninate, in or on pepper, black at 1 part per million ppm. That document referenced a summary of the petition prepared by American Spice Trade Association, the registrant, which is available in the docket, http www.regulations.gov.
Comments were received on the notice of filing. EPAs response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has modified the tolerance levels on black pepper. The reason for these changes is explained in Unit IV.D.

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III. Aggregate Risk Assessment and Determination of Safety FFDCA section 408b2Ai 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. . . .
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 metalaxyl including exposure resulting from the tolerances established by this action.
EPAs assessment of exposures and risks associated with metalaxyl 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. EPA conducted a human health risk assessment to evaluate the safety of the requested tolerances and the assessment Metalaxyl Human Health Risk Assessment for the Proposed Tolerances in/on White and Black Pepper without a U.S. Registration is found in docket ID number EPAHQOPP20200009 at www.regulations.gov. In that document, EPA evaluated the available hazard and exposure data to conduct dietary, residential, and aggregate assessment to determine risk to human health and refers back to the full discussions of the hazard profile, residue chemistry database, and residential exposures
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contained in the previous human health risk assessment conducted for the registration review of metalaxyl/
mefenoxam. The human health risk assessment Metalaxyl, Mefenoxam metalaxyl-m Human Health Draft Risk Assessment for Registration Review is located in docket EPAHQOPP2009
08630023.
The Draft Risk Assessment reflects both mefenoxam and metalaxyl. The Agency compared the available chemistry and toxicity data for mefenoxam and metalaxyl and concluded that the toxicity studies for both chemicals can be combined for hazard characterization and doseresponse assessment because the two chemicals have similar toxicity and identical chemical structures.
In rat and dog repeat dose i.e., subchronic and chronic oral toxicity studies, there were no indications of adverse effects up to the highest dose tested HDT. Adverse effects i.e., convulsions that occurred minutes after dosing were only observed from acute exposure to rats.
There was no evidence of increased susceptibility following preor postnatal exposure in the prenatal developmental toxicity studies or the reproduction and fertility effects study in the animals treated with metalaxyl. In the rat developmental toxicity study of metalaxyl, maternal toxicity consisted of dose-related increased incidence of convulsions that occurred shortly after dosing, as well as other clinical signs. In a range-finding acute neurotoxicity study of mefenoxam, females showed abnormal functional observation battery findings at doses lower than males, but higher than in the rat developmental study. However, there was no indication of toxicity up to the HDT in the mefenoxam subchronic neurotoxicity study, which confirms the lack of adverse effects observed in all other repeat-dose studies.
There was no indication of immunotoxicity in a mouse immunotoxicity study of mefenoxam.
Metalaxyl is classified as Not Likely to be Carcinogenic to Humans based on the lack of evidence of carcinogenicity in the metalaxyl carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats.
B. Toxicological Points of Departure/
Levels of Concern Once a pesticides toxicological profile is determined, EPA identifies toxicological points of departure POD
and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards
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