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Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations
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assessments will not underestimate the exposure and risks posed by fluxametamide.
E. 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. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. 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.
1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, fluxametamide is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluxametamide from food only will utilize less than 1%
of the cPAD for all population subgroups. There are no residential uses for fluxametamide.
3. Short-and intermediate-term risk.
Shortand intermediate-term aggregate exposure takes into account shortand intermediate-term residential exposure plus chronic exposure to food and water considered to be a background exposure level. Because fluxametamide is not registered in the United States, the only exposures will be dietary, from residues in or on imported tea;
therefore, no short-term or intermediateterm residential exposure is expected.
Because there is no shortor intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD which is at least as protective as the POD used to assess short-term risk, no further assessment of shortor intermediateterm risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating shortand intermediate-term risk for fluxametamide.
4. Aggregate cancer risk for U.S.
population. As stated in Unit III.A., EPA
has concluded that the chronic reference dose RfD will adequately account for all repeated exposure/
chronic toxicity, including carcinogenicity, which could result from exposure to fluxametamide. Based
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on the lack of chronic risk at regulated levels of exposure, EPA concludes that exposure to fluxametamide will not pose an aggregate cancer risk.
5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fluxametamide residues.
IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology high-performance liquid chromatography method with tandem mass spectrometry detection LC/MS/
MS, Method NCI2012101/NCI2013
017 is available to enforce the tolerance expression.
The method 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 Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA
may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408b4 requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established an MRL for fluxametamide.
C. Revisions to Petitioned-For Tolerances The petition requested a tolerance for residues of fluxametamide in or on tea.
Since dried tea is the commodity that enters commerce, EPA is establishing the tolerance for the processed commodity tea, dried rather than tea, plucked leaves. EPA is also establishing a tolerance for tea, instant, which is another processed commodity of tea, plucked leaves, and EPA has
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determined that the same tolerance of 5
ppm is appropriate for instant tea.
V. Conclusion Therefore, tolerances are established for residues of fluxametamide, including its metabolites and degradates, in or on tea, dried at 5 ppm and tea, instant at 5 ppm.
VI. Statutory and Executive Order Reviews This action establishes tolerances 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 tolerances 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 Government and the States or Tribal Governments, or on the distribution of
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