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Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Rules and Regulations IV. Other Considerations A. Analytical Enforcement Methodology An adequate tolerance enforcement method, gas chromatography with nitrogen-phosphorus detection GC/
NPD method AG575B, is available for the determination of residues of difenoconazole in/on plant commodities. An adequate enforcement method, gas chromatography with mass spectrometry detection GC/MSD
method AG676A, is also available for the determination of residues of difenoconazole per se in/on canola and barley commodities. A confirmatory method, GC/MSD method AG676, is also available.
An adequate tolerance enforcement method, Method REM 147.07b, is available for livestock commodities. The method determines residues of difenoconazole and CGA205375 in livestock commodities by liquid chromatography with tandem mass spectrometry detection LCMS/MS.
Adequate confirmatory methods, Method AG544A and Method REM
147.06, are available for the determination of residues of difenoconazole and CGA205375, respectively, in livestock commodities.
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.

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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.
Codex has established MRLs for residues of difenoconazole in/on olive commodities using the same data submitted in support of the U.S.
tolerances with no U.S. registrations.
Codex stipulates that residues should be expressed on a whole-fruit basis. The U.S. recommended tolerance level for olive, with pit 2 ppm is harmonized with the Codex MRL for residues of difenoconazole in/on table olives 2
ppm. In addition, a tolerance is being set at 3 ppm on olive, defined in OCSPP
Guideline 860.1000 as fruits after removal of the stems and pits, which is the commodity analyzed for enforcement.

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Codex has not established MRLs for residues of difenoconazole in/on pepper, black. MRLs for of difenoconazole in/on peppercorn black, green and white at 0.3 ppm have been established in the European Union EU.
Discussion on why EPA did not harmonize with that tolerance is covered in the Responses to Comments section in Unit IV.B.
A Codex MRL for difenoconazole has been established at 4 ppm in/on pome fruit for post-harvest use. Codex includes Japanese persimmon in the pome fruit group. The tolerance being set at this time is based on late-season foliar use rather than post-harvest use;
therefore, the tolerances are not the same and harmonization is not possible.
C. Responses to Comments EPA received one comment on the docket for difenoconazole in/on black pepper EPAHQOPP20200345
opposing pesticide residues in food, although no substantive information was provided for EPA to take into consideration in its safety assessment.
The commenter generally expressed concern about the potential for exposure to difenoconazole to be carcinogenic.
EPA has evaluated the available data on carcinogenicity and exposure and determined that aggregate exposure to difenoconazole will not cause a cancer risk. In addition, the commenter expressed concern about fluoride in chemicals; however, difenoconazole molecules do not contain any fluoride.
The FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when the Agency can determine that such residues are safe. EPA has made that determination for the tolerances subject to this action, and the commenter provided no information relevant to that conclusion.
A comment from the government of the Peoples Republic of China P.R.
China was received through the World Trade Organization comment process.
This comment has been posted to the docket for difenoconazole in/on black pepper EPAHQOPP20200345. It requests that EPA set the tolerance on pepper, black at 0.3 ppm to match the current EU tolerance. EPA consulted with the registrant regarding the possibility to harmonize the tolerance with the EU limit standards. The registrant, through its consultant, recommended against harmonizing the tolerance with the current EU MRL for residues of difenoconazole in/on black pepper 0.3 ppm based on the following rationale. According to the registrant, the current EU MRL is not based on supporting data and is of unknown
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origin. It is expected that any EU MRL
not supported by data, such as in this case, would be evaluated during the Article 12 EU MRL Review Process. If no supporting data are submitted during the review process, the EU MRL would be reduced to 0.01 ppm by 2026. The Agency notes that it is also possible that the same data that support the tolerance with no U.S. registration established in this action 0.1 ppm could be submitted as supporting data to the EU and/or Codex, in which case future harmonization is possible. In addition, the P.R. China comment requests that EPA share the data and reports supporting the tolerance. More detailed information about the Agencys analysis can be found in the risk assessments posted to docket ID number EPAHQ
OPP20200345.
D. Revisions to Petitioned-For Tolerances Although the summary of the petition cited in Unit II of this preamble indicated a request for a tolerance on olive, the actual petition sought a tolerance for olive including oil. The originally requested tolerance of 2 ppm in/on olive including oil has been revised to 2 ppm in/on olive, with pit and 3 ppm in/on olive. The commodity definition commonly used in the 40 CFR is olive, meaning fruits after removal of the pits, and the terminology olive, with pit is descriptive of the Codex residue expression. Use of both terms allows harmonization with Codex while also maintaining the way that the commodity is analyzed for enforcement in the United States.
V. Conclusion Therefore, tolerances are established for residues of difenoconazole, in or on olive at 3 ppm; olive, with pit at 2 ppm;
pepper, black at 0.1 ppm; and persimmon, Japanese at 0.7 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
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