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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations B. How can I get electronic access to other related information?

II. Summary of Petitioned-For Tolerance
You may access a frequently updated electronic version of EPAs tolerance regulations at 40 CFR part 180 through the Government Publishing Offices eCFR site at http www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.

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 pesticide petition PP 9F8799 by Makhteshim Agan of North America d/
b/a ADAMA, 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested that 40 CFR 180.680
be amended by establishing tolerances for residues of the nematicide fluensulfone, in or on soybean, seed at 0.1 parts per million ppm; soybean, forage at 7.0 ppm; and soybean, hay at 20 ppm. That document referenced a summary of the petition prepared by Makhteshim Agan of North America, the petitioner, which is available in the docket, http www.regulations.gov.
Two 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 is establishing a tolerance that varies from what is requested. The reason for these changes is explained in Unit IV.D.

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C. How can I file an objection or hearing request?
Under FFDCA section 408g, 21
U.S.C. 346ag, 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
OPP20200118 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 October 18, 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
20200118, 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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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 therein, 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 fluensulfone, including exposure resulting from the tolerance established by this action.

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EPAs assessment of exposures and risks associated with fluensulfone follows.
In an effort to streamline Federal Register publications, EPA is not reprinting here summaries of its analyses 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 April 13, 2018 tolerance rulemaking for residues of fluensulfone that remain unchanged for an understanding of the Agencys rationale in support of this rulemaking. See 83 FR 15971 FRL
997576. Those sections are: Units III.A
Toxicological Profile; III.B.
Toxicological Points of Departure/
Levels of Concern; and III.C. Exposure Assessment, except as explained in the next paragraphs; III.D. Safety Factor for Infants and Children.
Exposure assessment updates. EPAs exposure assessments have been updated to include the additional exposure from use of fluensulfone on soybeans. EPAs aggregate exposure assessment incorporated this additional dietary exposure, as well as exposure from drinking water and from residential sources. The new use does not result in an increase in the estimated residue levels in drinking water or in exposure from residential sources relative to those used in the last assessment.
Further information about EPAs risk assessment and determination of safety supporting the new fluensulfone tolerance can be found at http
www.regulations.gov in the document titled Fluensulfone. Human Health Risk Assessment for a New Use on Soybean. in docket ID EPAHQOPP
20200118.
Assessment of aggregate risks. EPA
determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose aPAD and chronic population adjusted dose cPAD. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure PODs to ensure that an adequate margin of exposure 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: The acute dietary risk estimate is 21% of the aPAD
for infants <1 year old, the group with the highest exposure. Chronic dietary risks are below the Agencys level of concern: 4.8% of the cPAD for infants <1 year old, the group with the highest
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