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Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations 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 including exposure resulting from the tolerance established by this action.
EPAs assessment of exposures and risks associated with emamectin follows.
In an effort to streamline Federal Register publications, EPA is not reprinting sections of the rule that would repeat what has been previously published in tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, and republishing the same sections is unnecessary. EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.
EPA has previously published a number of tolerance rulemakings for emamectin, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to emamectin and established tolerances for residues of that chemical.
EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.
Toxicological profile. The Toxicological Profile of emamectin remains unchanged from the Toxicological Profile in Unit III.A. of the August 27, 2019 rulemaking 84 FR
44718 FRL999710. Refer to that section for a discussion of the Toxicological Profile of emamectin.
Toxicological points of departure/
Levels of concern. The Toxicological Points of Departure/Levels of Concern used for the safety assessment remain unchanged from Unit III.B. of the August 27, 2019 rulemaking. For a summary, refer to that discussion.
Exposure assessment. Much of the exposure assessment remains the same, although updates have occurred to accommodate exposures from the petitioned-for tolerance. These updates
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are discussed in this section; for a description of the rest of the EPA
approach to and assumptions for the exposure assessment, see Unit III. C. of the August 27, 2019 rulemaking.
EPAs dietary exposure assessments have been updated to include the additional exposure from the new use of emamectin on soybean, seed. All other assumptions in the exposure assessments for emamectin remain the same as in the August 27, 2019
rulemaking.
Drinking water and non-occupational exposures. Drinking water exposures and residential non-occupational exposures are not impacted by the new use, and thus have not changed since the last assessment.
There are no proposed residential uses of emamectin that would result in residential exposures. As a result, there are no residential risk estimates recommended for use in the aggregate risk assessment for emamectin.
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.
For the new uses of emamectin, the quantitative exposures to residues of emamectin remain unchanged, and the cumulative exposures remain identical to those as assessed within the 2021
cumulative assessment. There are no risks of concern resulting from these cumulative exposures.
Safety factor for infants and children.
The scientific information underpinning EPAs prior safety factor determination remains unchanged from the August 27, 2019 rulemaking. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act FQPA safety factor. See Unit III.D. of the August 27, 2019 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 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 points of departure to ensure that an adequate margin of exposure MOE
exists. For linear cancer risks, EPA
calculates the lifetime probability of
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acquiring cancer given the estimated aggregate exposure.
Acute dietary risks are below the Agencys level of concern: 30% 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: 3.8% of the chronic population adjusted dose cPAD for children 1 to 2 years old, the group with the highest exposure. Emamectin is classified as Not likely to be Carcinogenic to Humans, therefore, a cancer dietary exposure analysis was not performed.
There are no registered uses of emamectin that would result in residential exposure; therefore, aggregate exposure and risk estimates are equivalent to the dietary exposure and risk estimates and are not of concern. Using the exposure assumptions described for acute and chronic exposures, EPA has concluded the combined dermal and inhalation exposures result in aggregate margins of exposures for handler scenarios ranging from 200 to 27,000 and post-application scenarios ranging from 48,000 to 750,000, which are not of concern because they exceed EPAs level of concern MOEs less than or equal to 100.
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 residues. More detailed information about the Agencys analysis can be found at http
www.regulations.gov in the document titled Emamectin Benzoate; Human Health Risk Assessment for a Proposed New Use on Soybean in docket ID
number EPAHQOPP20210066.
IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the August 27, 2019
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 emamectin on soybeans.

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