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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations
Ethaboxam. Human Health Risk Assessment for Non-food Seed Treatment, supports the tolerances established in March 9, 2012, and can be found at http www.regulations.gov at docket ID EPAHQOPP20110908
0003. Although the Agency incorporated the assumptions for exposure assessment from the March 9, 2012, final rule and risk assessment, the Agency conducted a revised risk assessment to incorporate exposure to residues of ethaboxam from use as a seed treatment on sugar beets. The updated risk assessment, titled Ethaboxam. Human Health Risk Assessment Supporting the Proposed New Use on Sugar Beet Seeds, is in docket ID number EPAHQOPP2019
0230.
EPAs exposure assessments have been updated to include the additional exposure from use of ethaboxam on sugar beet, relied on tolerance-level residues, an assumption of 100 percent crop treated PCT, and 2018 default processing factors for all processed commodities, except for potato, grape, and sugar beet proceeded commodities, for which the processing studies demonstrated no concentration. EPAs aggregate exposure assessment incorporated this additional dietary exposure, which includes exposure through drinking water. However, drinking water exposures are not impacted by the new use on sugar beet, and thus have not changed since the last assessment. Additionally, although sugar beet molasses and dried pulp are considered significant livestock feed items, the requested new use on sugar beets will not result in the need to establish ethaboxam tolerances in livestock commodities.
An acute dietary risk assessment was not conducted since effects attributable to a single exposure were not identified.
Chronic dietary risks are below the Agencys level of concern: 36% of the chronic population adjusted dose cPAD for children 1 to 2 years old, the group with the highest exposure. Due to no existing registered or proposed residential uses associated with ethaboxam, there is not expected to be any residential handler exposure or post-application dermal exposures.
Residential post-application oral and inhalation exposures are not expected.
Since there are no residential uses, the aggregate exposure is equal to the dietary exposure and thus is not of concern.
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
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infants and children from aggregate exposure to ethaboxam residues. More detailed information on the subject action to establish tolerances in or on beet, sugar, roots can be found in the document entitled, Ethaboxam. Human Health Risk Assessment Supporting the Proposed New Use on Sugar Beet Seeds by going to http
www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES. Locate and click on the hyperlink for docket ID
number EPAHQOPP20190230.
IV. Other Considerations A. Analytical Enforcement Methodology There are adequate residue analytical methods for enforcing tolerances for ethaboxam residues of concern in/on the registered plant commodities. The methods include high-performance liquid chromatography with tandem mass-spectrometric detection LCMS/
MS for determining residues in/on sugar beets.
The methods may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 207555350;
telephone number: 410 3052905;
email address: residuemethods@
epa.gov.
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 ethaboxam in or on beet, sugar, roots; however, Canadas Pest Management Regulatory Agency PMRA is simultaneously evaluating the proposed use for ethaboxam on sugar beet seeds. EPA is establishing the same tolerance level for beet, sugar, roots as PMRAs proposed MRL of 0.03
ppm. Therefore, there are no harmonization issues.
C. Revisions to Petitioned-For Tolerances The requested tolerance in beet, sugar, root was modified to read beet, sugar, roots to be consistent with Agency naming practices. The petitioned-for tolerance level of 0.01
ppm in beet, sugar, roots has been modified to 0.03 ppm based on the pertrial average residue corrected for all
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field trial dissipation. This is consistent with the Organization for Economic Cooperation and Development OECD
tolerance calculation procedure when all residues are corrected for apparent storage stability decline.
V. Conclusion Therefore, tolerances are established for residues of ethaboxam in or on beet, sugar, roots at 0.03 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 not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 66
FR 28355, May 22, 2001 or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks 62 FR 19885, April 23, 1997, nor is it considered a regulatory action under Executive Order 13771, entitled Reducing Regulations and Controlling Regulatory Costs 82
FR 9339, February 3, 2017. This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act PRA 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations 59 FR 7629, February 16, 1994.
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408d, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act RFA 5 U.S.C. 601 et seq., do not apply.
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA
section 408n4. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National
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