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Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations reprinting sections that have not changed from previous rulemakings for the same pesticide. On October 19, 2018, EPA published in the Federal Register a final rule establishing tolerances for residues of boscalid in or on multiple commodities based on the Agencys conclusion that aggregate exposure to boscalid is safe for the general population, including infants and children. See 83 FR 52991 EPA
HQOPP20170310. Refer to the following sections from the previous tolerance rulemaking for boscalid that have remained the same under the current risk assessment: Units III.A
Toxicological Profile; III.B
Toxicological Points of Departure/
Levels of Concern; III.C. Exposure Assessment, except as explained below;
and III.D. Safety Factor for Infants and Children. EPA has conducted an updated human health risk assessment to evaluate the safety of the requested tolerances, which is limited to an updated dietary exposure and risk assessment, and subsequent updates to the aggregate exposure and risk assessment. See Boscalid. Human Health Risk Assessment for the Establishment of a Permanent Tolerance Without a U.S. Registration on Tea.
D456100, 04/01/2021, which is available in the docket established by this action, EPAHQOPP20200050.
Updates to exposure assessment.
EPAs dietary food and drinking water exposure assessments have been updated to include the potential additional exposure from the tolerance for boscalid residues in or on tea, dried and tea, instant. The exposure assessments relied on tolerance-level residues for all crops and an assumption of 100 percent crop treated PCT as the October 19, 2018, final rule. Exposure in drinking water and from residential sources are not impacted by the increased tolerance on tea, dried and tea, instant because the tolerances are without U.S. registration.
Assessment of aggregate risks. An acute dietary exposure assessment was not conducted because there were no observed effects attributable to a single dose. Chronic dietary risks are below the Agencys level of concern of 100%
of the chronic population adjusted dose cPAD: 60% of the cPAD for children 1 to 2 years old, the most highly exposed population subgroup.
For the aggregate risk assessment, exposures to boscalid in food and drinking water are combined with residential exposures for the relevant exposure duration period. There is potential for short-term aggregate exposure to boscalid via dietary which is considered background exposure and
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residential which is considered primary exposure pathways. The shortterm aggregate margins of exposure MOEs are 160 for children 6 to 11
years old, 360 for youth 11 to 16 years old, and 130 for adults LOC = 100, which are not of concern because they exceed EPAs level of concern MOEs less than or equal to 100.
A separate cancer dietary assessment was not conducted since boscalid was classified by the Cancer Assessment Review Committee CARC as suggestive evidence of carcinogenicity; and the chronic exposure assessment is protective of any cancer risks. Therefore, based on the chronic exposure assessment, which accounts for potential carcinogenicity, EPA does not expect boscalid to pose a cancer risk.
C. Determination of Safety 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 boscalid residues. More detailed information about the Agencys analysis can be found in the document entitled, Boscalid. Human Health Risk Assessment for the Establishment of a Permanent Tolerance Without a U.S.
Registration on Tea. D456100, 04/01/
2021 by going to http
www.regulations.gov.
IV. Other Considerations A. Analytical Enforcement Methodology Adequate methods exist for both plants and livestock. In plants, the parent residue is extracted using an aqueous organic solvent mixture followed by liquid/liquid partitioning and a column clean up. Quantitation is by gas chromatography using mass spectrometry GC/MS or liquid chromatography in tandem with mass spectrometric detection LC/MS/MS. In livestock, the residues are extracted with methanol. The extract is treated with enzymes in order to release the conjugated glucuronic acid metabolite.
The residues are then isolated by liquid/
liquid partition followed by column chromatography. The hydroxylated metabolite is acetylated followed by a column clean-up. The parent and acetylated metabolite are quantitated by gas chromatography with electron capture detection.
Adequate enforcement methodology, extraction using an aqueous organic solvent mixture followed by liquid/
liquid partitioning and a column clean up with quantitation by gas
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chromatography using mass spectrometry GC/MS or liquid chromatography in tandem with mass spectrometric detection LC/MS/MS, 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.
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 a MRL for boscalid. Taiwan has an MRL for residues of boscalid in/
on dried tea leaves at 10 ppm, and Japan has an MRL of residues of boscalid in/
on dried tea leaves at 60 ppm. The tolerance expression for Taiwan and Japan are harmonized with the US
tolerance definition in crops as parent boscalid only but do not metabolites and degradates. All international MRLs fall below the calculated tolerance value of 70 ppm.
C. Revisions to Petitioned-For Tolerances The petitioned-for tolerance for residues on the commodity tea at 80
ppm is revised so that there will be two separate tolerances for residues on tea, dried and tea, instant each at 70 ppm and corrected commodity definitions.
The tolerance is also revised pursuant to a difference in how the tolerances are calculated. The registrant calculated a processing factor for dried black tea as 4.1x and used the field trial values from the fresh leaves at 7-days. EPA
determined the processing factor to be no greater than 2.54x and extrapolated the 7-day residues for black tea based on the combination of the processing factor and the decline trend for fresh leaves.
V. Conclusion Therefore, tolerances are established for residues of boscalid, in or on Tea, dried; and Tea, instant at 70 ppm.

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