Source: https://www.federalregister.gov/documents/2017/07/05/2017-14108/flubendiamide-pesticide-tolerances
Timestamp: 2017-11-19 18:21:28
Document Index: 567909018

Matched Legal Cases: ['art 178', 'art 178', 'art 2', 'art\n2', '§\u2009180', '§\u2009180']

82 FR 30979
30979-30982 (4 pages)
FRL-9962-13
https://www.federalregister.gov/d/2017-14108 https://www.federalregister.gov/d/2017-14108
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2007-0099, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.
Animal production (NAICS code 112).Start Printed Page 30980
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0099 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 5, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2007-0099, by one of the following methods:
In the Federal Register of August 12, 2016 (81 FR 53379) (FRL-9949-53), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announced the filing of a pesticide petition (PP 6E8463) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808-2951. This petition requested that 40 CFR 180.639 be amended by establishing an import tolerance for residues of flubendiamide, N2-[1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, in or on the processed commodity of dried tea at 60 parts per million (ppm). This document referenced a summary of a petition prepared by Nichino America, Inc., the registrant, which is available in the docket, http://www.regulations.gov. This tolerance was requested to cover residues of flubendiamide in or on tea resulting from uses of this pesticide on tea outside the United States; there is no current U.S. registration for use of flubendiamide on tea. In order to harmonize with Codex, EPA is establishing a tolerance for residues of flubendiamide in or on tea at 50 ppm. The available residue data supports this tolerance level. A revised Section F was submitted by Nichino America, Inc. to support this change to the petitioned-for tolerance. There were no comments received in response to the notice of filing.
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 flubendiamide including exposure resulting from the tolerance established by this action.
In the Federal Register of December 12, 2012 (77 FR 73940) (FRL-9373-3), EPA amended tolerances for residues of flubendiamide in or on apple, wet pomace and fruit, pome, group 11. EPA is relying upon significant portions of those risk assessments and the corresponding findings made in the December 12, 2012 Federal Register document in support of this action for the following reasons. The toxicity profile of flubendiamide has not changed. Much of the exposure profiled remains the same as well because there is no U.S. registration associated with the tea use (i.e., the estimated drinking water exposures reported in 2012 are not expected to change nor is there any need to conduct a residential exposure assessment due to the lack of proposed or existing residential uses for flubendiamide). The Agency did take into consideration the potential additional dietary exposure to flubendiamide as a result of residues in or on imported tea. Aggregating that exposure with the dietary exposure estimated in the December 2012 tolerance assessment resulted in no change to the acute dietary exposure (3.1% of the aPAD for the general U.S. population and 5.5% of the aPAD for children 1-2 years old, the most highly exposed population subgroup) and only a 1% change in the chronic dietary risk (21% of the cPAD) for the general U.S. population and an increase of 9% in the chronic dietary risk (67% of the cPAD) for children 1-2 years old, the most highly exposed population subgroup. The Agency's findings concerning cumulative effects and the children's safety factor as reflected in the December 2012 tolerance rulemaking are also relied upon in this action.
Based upon the risk assessments supporting the December 12, 2012 Federal Register document, the findings therein, and the updated risk assessment accounting for the residues of flubendiamide on imported tea, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and Start Printed Page 30981children from aggregate exposure to flubendiamide residues.
For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer to the December 12, 2012, Federal Register document and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2007-0099. Further information about EPA's determination that an updated risk assessment was not necessary may be found in the document, “Flubendiamide: Human Health Risk Assessment for the Petition for a Tolerance Without U.S. Registration for Residues in/on Tea.” in docket ID number EPA-HQ-OPP-2007-0099.
An independently validated liquid chromatography/tandem mass spectrometry (LC/MS/MS) method, Method 00816/M002, was previously submitted for the determination of residues of in/on samples of plant commodities. The validated limit of quantitation (LOQ) is 0.01 ppm for each analyte in each matrix.
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 408(b)(4). 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 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. There is currently a Codex MRL for tea established at 50 ppm; therefore, the U.S. EPA is establishing a tolerance on tea at the same level to harmonize with Codex.
If only dried tea data are submitted for imported tea (data in/on the RAC are not required for imported tea) and the tolerance level based on these data is also meant to cover for detectable residues in instant tea (may be demonstrated by data depicting detectable residues in brewed tea), then the correct commodity definition for tolerance setting should be “tea” to cover incurred residues in or on all tea commodities and eliminate any regulatory ambiguity. In order to harmonize with Codex, EPA is establishing a tolerance for residues of flubendiamide in or on tea at 50 ppm. The available residue data supports this tolerance level. A revised Section F was submitted by Nichino America, Inc. to support this change to the petitioned-for tolerance.
Therefore, a tolerance is established for residues of flubendiamide, N2-[1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, in or on tea at 50 ppm. At this time, there is no U.S. registration for use of flubendiamide on tea.
End Authority Start Printed Page 30982 Start Amendment Part
2. In § 180.639, add alphabetically the entry “Tea” to the table in paragraph (a) to read as follows:
§ 180.639
Tea 1 50
1 There are no U.S. registrations as of July 5, 2017, for use of flubendiamide on tea.
[FR Doc. 2017-14108 Filed 7-3-17; 8:45 am]