Source: https://www.federalregister.gov/documents/2018/03/15/2018-05284/trinexapac-ethyl-pesticide-tolerances
Timestamp: 2018-05-28 08:18:29
Document Index: 210730931

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 2', 'art 180', '§\u2009180']

A Rule by the Environmental Protection Agency on 03/15/2018
This regulation is effective March 15, 2018. Objections and requests for hearings must be received on or before May 14, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
83 FR 11420
FRL-9973-20
Trimexapac-ethyl. Section 3 Registration Request for New Uses...
https://www.federalregister.gov/d/2018-05284 https://www.federalregister.gov/d/2018-05284
This regulation establishes a tolerance for residues of trinexapac-ethyl in or on poppy, seed. Syngenta Crop Protection, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA) in order to cover residues of trinexapac-ethyl in imported poppy seed commodities.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0365, 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.
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-2016-0365 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 May 14, 2018. 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-2016-0365, by one of the following methods:
In the Federal Register of November 30, 2016 (81 FR 86312) (FRL-9954-06), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8462) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, NC 27419.The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the herbicide trinexapac-ethyl, ethyl 4-(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylate expressed as its primary metabolite trinexpac, 4-(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylic acid, in or on poppy, seed at 8 parts per million (ppm). That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA Start Printed Page 11421defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
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 trinexapac-ethyl including exposure resulting from the tolerances established by this action.
In the Federal Register of May 20, 2015 (80 FR 28843) (FRL-9926-62), EPA amended tolerances for herbicide trinexapac-ethyl, ethyl 4-(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylate expressed as its primary metabolite trinexpac, 4-(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylic acid in or on several commodities. Because the majority of the Agency's conclusions remain the same, EPA is incorporating the discussions from the May 20, 2015, Federal Register document into this document and relying on the same supporting documents. The only difference is the potential to impact dietary exposure; because the use on poppy seeds is not approved in the United States, there is no impact on drinking water exposures or residential exposures.
The Agency has determined that a new dietary exposure assessment is not needed because poppy seed is not a significant part of the diet, and residues of trinexapac-ethyl do not concentrate in poppy seed oil. Therefore, residues in poppy seed oil are not expected to have an impact on the EPA's previous findings. Therefore, EPA relies upon the findings made in the May 20, 2015, Federal Register document, as well as the review of the poppy seed data in support of this rule. 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 trinexapac-ethyl residues.
For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances please refer to the May 20, 2015, Federal Register document and its supporting documents, available at http://www.regulations.gov in document “Trinexapac-ethyl; Pesticide Tolerances” (80 FR 28843, May 20, 2015) in docket ID number EPA-HQ-OPP-2014-0340; FRL-9926-62. Further information about EPA's determination that an updated risk assessment was not necessary may be found in the document “Trinexapac-ethyl. Section 3 Registration Request for New Uses on Imported Poppy Seeds. Summary of Analytical Chemistry and Residue Data” in docket ID number EPA-HQ-OPP-2016-0365.
Therefore, tolerances are established for residues of trinexapac-ethyl, ethyl 4-(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylate expressed as its primary metabolite trinexpac, 4-(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylic acid, in or on poppy, seed at 8 ppm.
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Start Printed Page 11422Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
2. In § 180.662 adding alphabetically the entry for “Poppy, seed imported” and footnote 1 to the table in paragraph (a) to read as follows:
Poppy, seed imported 1 8
1. There are no U.S. registrations for Poppy, seed as of March 15, 2018.
[FR Doc. 2018-05284 Filed 3-14-18; 8:45 am]