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Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations received by the Hearing Clerk on or before April 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 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
20200064, 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.

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II. Summary of Petitioned-For Tolerance In the Federal Register of April 15, 2020 85 FR 20910 FRL1000654, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 9F8810 by Syngenta Crop Protection, LLC, 410
Swing Road, Greensboro, NC 27409. The petition requested that 40 CFR 180.505
be amended by establishing a tolerance for residues of the insecticide emamectin benzoate a mixture of a minimum of 90% 4-epi-methylamino4-deoxyavermectin B1a and a maximum of 10% 4-epi-methlyamino4deoxyavermectin B1b benzoate, and its metabolites 8,9 isomer of the B1a and B1b in or on tea leaves at 0.2 parts per million ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, 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.

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Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from what is requested. The reason for these changes is 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
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 emamectin benzoate including exposure resulting from the tolerances established by this action. EPAs assessment of exposures and risks associated with emamectin benzoate follows.
In an effort to streamline Federal Register publications, EPA is not reprinting here summaries of its analysis that have previously appeared in the Federal Register in previous tolerance rulemakings for the same pesticide. To that end, this rulemaking refers the reader to several sections from the August 27, 2019 tolerance rulemaking for residues of emamectin benzoate that remain unchanged for an understanding of the Agencys rationale in support of this rulemaking. See 84
FR 44718 FRL999710. Those sections are: Units III.A Toxicological Profile; III.B. Toxicological Points of Departure/Levels of Concern; III.C.
Exposure Assessment, except as explained in the next paragraphs; III.D.
Safety Factor for Infants and Children;
and IV.A Analytical Enforcement Method.

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Exposure assessment updates. EPAs exposure assessments have been updated to include the additional exposure from residues of emamectin benzoate in or on tea commodities. The assessments continue to be refined as described in the August 27, 2019
tolerance rule preamble. The residues of emamectin benzoate on tea commodities is not being approved for domestic use, so no changes were made to EPAs drinking water assessment or residential exposure assessment.
Assessment of aggregate risks. EPA
determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD aPAD and chronic PAD cPAD. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.
Acute dietary risks are below the Agencys level of concern: 26% of the acute population adjusted dose aPAD
for children 1 to 2 years old, the population group of concern. Chronic dietary risks are below the Agencys level of concern: 3.4% of the chronic population adjusted dose cPAD for children 1 to 2 years old, the group with the highest exposure. As there are no residential exposures expected, aggregate risks are equivalent to the dietary risks, which are below the Agencys levels of concern. Based on the most recent screening-level cumulative exposure assessment, EPA has concluded the cumulative aggregate dietary and residential exposures for emamectin benzoate result in aggregate margins of exposures above the level of concern of 100 for all scenarios assessed and are not of concern.
Determination of safety. Therefore, based on the risk assessments and information described above, EPA
concludes there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to emamectin benzoate residues. More detailed information on the subject action to establish a tolerance in or on tea commodities can be found in the document entitled, Emamectin Emamectin Benzoate. Human Health Risk Assessment in Support of Establishing Tolerances without a U.S.
Registration for Residues of Emamectin in/on Tea Commodities by going to http www.regulations.gov. The referenced document is available in the docket established by this action, which
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