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Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Rules and Regulations
not impacted by the new uses, and thus have not changed since the last assessment. There were no changes to the drinking water analysis due to the estimated drinking water concentrations EDWC for terrestrial applications that were approximately 500- to 1,200-fold lower than concern levels. Therefore, the Agency has concluded that previous EDWCs are adequate.
Residential non-occupational exposures are also not impacted by the new uses. There are no new proposed residential uses for florasulam at this time; however, there are registered uses of florasulam on turfgrass, including residential lawns, golf courses, sports fields, sod farms and commercial turfgrass areas. Because all current florasulam labels with turf uses require handlers to wear personal protective equipment, EPA assumes that florasulam is applied by professional applicators, not residential homeowner applicators. Therefore, the current assessment does not consider exposure to residential handlers. This is different than the assessment supporting the July 25, 2018 rule, which relied on a 2009 assessment that included inhalation exposure to residential handlers. EPAs policy has changed since 2009 to reflect the assumption described above regarding labels that require personal protective equipment.
Post-application residential exposures were considered as part of the assessment. Due to lack of a dermal endpoint, only the incidental oral exposures for children 1 to less than 2
years old from use on residential turf were assessed. Margins of exposure MOEs ranged from 25,000 for hand-tomouth short-term exposure to 11,000,000 for incidental soil ingestion short-term exposure and were not of concern. More detailed information about the Agencys analysis can be found at http www.regulations.gov in the document titled Florasulam: Draft Human Health Risk Assessment for Registration Review in docket ID
number EPAHQOPP20200113.
Cumulative exposures. Section 408b2Dv of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity.
EPAs assessment of cumulative exposures has not changed since the July 25, 2018 rulemaking. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA
has not found a common mechanism of
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toxicity as to florasulam and any other substances and florasulam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA
has not assumed that florasulam has a common mechanism of toxicity with other substances.
Safety Factor for Infants and Children. The scientific information underpinning EPAs prior safety factor determination remains unchanged from the July 25, 2018 rulemaking. Therefore, EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act FQPA safety factor. See Unit III.D.
of the July 25, 2018 rulemaking for a discussion of the Agencys rationale for that determination.
Aggregate Risks and Determination of Safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose aPAD and the chronic PAD 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 to ensure that an adequate MOE exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.
An acute dietary risk assessment was not conducted as toxicological effects attributable to a single dose were not identified. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD: They are less than 1% of the cPAD for the U.S. population and all population subgroups.
Florasulam is classified as Not Likely to be Carcinogenic to Humans;
therefore, a cancer dietary exposure analysis was not performed.
Short-term aggregated risk included the incidental oral exposures and the average dietary exposures from food and drinking water sources. Short-term aggregated risk estimates for the most highly exposed child population, children 1 to less than 2 years old, results in an MOE of 17,000 and is not of concern because it is greater than the level of concern of 100. As stated in the July 25, 2018 rule, florasulam is not registered for any use patterns that would result in intermediate-term residential exposure due to the intermittent nature of applications.
Because there is no intermediate-term residential exposure and chronic dietary exposure has been assessed under the appropriately protective cPAD, EPA
relies on the chronic dietary risk assessment for evaluating intermediateterm risk for florasulam.

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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 florasulam residues. More detailed information about the Agencys analysis can be found at http
www.regulations.gov in the document titled Florasulam: Human Health Risk Assessment for the Proposed New Use on Seedlings and Grasses Grown for Seed in docket ID number EPAHQ
OPP20200113.
IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the July 25, 2018 rulemaking.
B. International Residue Limits In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits MRLs established by the Codex Alimentarius Commission Codex, as required by FFDCA section 408b4.
The Codex has not established MRLs for residues of florasulam in/on grasses.
C. Revisions to Petitioned-For Tolerances After the NOF was published, the petitioner revised their tolerance request to establish a tolerance for grass, forage, fodder and hay, group 17 at 0.02 ppm.
The Agency determined that the residue data support that tolerance and therefore is establishing the tolerance for the crop group.
V. Conclusion Therefore, regional tolerances are established for residues of florasulam, N-2, 6-difluorophenyl-8-fluoro-5methoxy 1, 2, 4 triazole 1, 5cpyrimidine-2-sulfonamide, in or on grass, forage, fodder and hay, group 17
at 0.02 ppm.
VI. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408d in response to a petition submitted to the Agency. The Office of Management and Budget OMB has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review 58 FR 51735, October 4, 1993. Because this action has been exempted from review under Executive Order 12866, this action is
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