Source: https://www.federalregister.gov/documents/2020/07/01/2020-13048/cyflumetofen-pesticide-tolerances
Timestamp: 2020-07-06 00:31:11
Document Index: 656577176

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

This regulation is effective July 1, 2020. Objections and requests for hearings must be received on or before August 31, 2020 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
39491-39494 (4 pages)
EPA-HQ-OPP-2019-0046
FRL-10009-25
https://www.federalregister.gov/d/2020-13048
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2019-0046, 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-2019-0046 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 August 31, 2020. 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 Start Printed Page 39492pursuant 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-2019-0046, by one of the following methods:
In the Federal Register of April 19, 2019 (84 FR 16430) (FRL-9991-14), 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 8E8724) by IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide cyflumetofen, 2-methoxyethyl a-cyano-a-[4-(1,1-dimethylethyl)phenyl]-b-oxo-2-(trifluoromethyl)benzenepropanoate, including its metabolites and degradates, to be determined by measuring only cyflumetofen, in or on the agricultural commodities: Cucumber at 0.15 parts per million (ppm); fruit, stone, group 12-12 at 2.0 ppm; plum, prune, dried at 0.41 ppm; strawberry at 0.80 ppm; and vegetable, fruiting, group 8-10 at 2.0 ppm. The petition also requested that upon approval of the above tolerances that 40 CFR 180.677 be amended by revising or removing the existing tolerances for residues of the insecticide cyflumetofen, in or on the agricultural commodities strawberry at 0.60 ppm and tomato at 0.40 ppm. That document referenced a summary of the petition prepared by BASF, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA is establishing some tolerances at different levels than requested and in some cases is establishing tolerances for different commodities than requested. The reason for these changes is explained in Unit IV.C.
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 cyflumetofen including exposure resulting from the tolerances established by this action.
On May 8, 2019, EPA published in the Federal Register a final rule establishing a tolerance for residues of the insecticide cyflumetofen in or on tea, dried. See 84 FR 20037 (FRL-9990-60). That document contains a summary of the toxicological profile, assumptions for dietary exposure assessment, cumulative risk, and the safety factor for children, which have not changed. Further information about EPA's risk assessment and determination of safety supporting the tolerances established in the May 8, 2019 Federal Register action can be found at http://www.regulations.gov in the document titled, “Cyflumetofen. Human Health Risk Assessment to Support New Uses on Imported Tea” dated March 4, 2019. The document can be found in docket ID EPA-HQ-OPP-2017-0532.
The Agency conducted a revised risk assessment to incorporate exposure to residues of cyflumetofen from use on the cucumber, the stone fruit group 12-12, strawberries, and the fruiting vegetable group 8-10. EPA's aggregate exposure assessment incorporated this additional dietary exposure, as well as exposure in drinking water, although drinking water exposures are not impacted by the new uses. In addition, the aggregate exposure assessment no longer includes residential handler exposures; no post-application exposures were assessed due to a lack of residential post-application exposures and lack of dermal hazard.
As indicated in the supporting documents, no acute dietary exposure and risk analysis was performed for cyflumetofen since there were no appropriate studies identified in the toxicology database that demonstrated evidence of toxicity attributable to a single dose. Chronic dietary (food and water) risks are below the Agency's level of concern of 100% of the chronic population adjusted dose (cPAD); they are 3% of the cPAD for children 1-2 years old, the group with the highest exposure level. Because EPA has determined there are no residential exposures, the chronic dietary risk is the same as the overall aggregate risk for cyflumetofen.
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 cyflumetofen residues.
More detailed information on the subject action to establish a tolerance in or on cucumber, the stone fruit group 12-12, prunes, strawberries, and the fruiting vegetable group 8-10 can be found in the document titled, “Cyflumetofen. Human Health Risk Assessment for the Section 3 Registration Action for New Uses on Fruiting Vegetable (Crop Group 8-10), Stone Fruits (Crop Group 12-12), and Greenhouse Uses on Fruiting Vegetable, Cucumber, and Strawberry”, dated April 29, 2020, by going to http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2019-0046.
An adequate analytical method is available to enforce the Agency-recommended tolerances for Start Printed Page 39493cyflumetofen in plant commodities. The high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method, BASF D1003, has been adequately validated, has undergone a successful ILV (independent laboratory validation), is considered adequately radio-validated and has been reviewed by the Agency for appropriateness as an enforcement method. Cyflumetofen has also been subjected to analysis by the Food and Drug Administration (FDA) multi-residue method (MRM) protocols. Cyflumetofen is not adequately recovered through any of the FDA multi-residue protocols.
There are Codex MRLs established for cyflumetofen residues in/on strawberry (0.6 ppm) and tomato (0.3 ppm). The strawberry tolerance is harmonized with Codex. The tolerance for tomato is not harmonized with Codex; harmonization is not possible at this time since lowering the newly established U.S. tolerance may result in over-tolerance residues in the United States.
EPA is establishing the tolerance for cucumber at 0.3 ppm rather than the petitioned-for tolerance level of 0.15 ppm to fully account for residue loss from the field trial samples during freezer storage from the time of harvest to the time of analysis.
EPA is establishing tolerances for the subgroups in the stone fruit crop group 12-12 rather than the whole crop group based on the highest maximum residue limit (MRL) calculated for each of the representative crops: Cherry (1.5 ppm), peaches (0.4 ppm), and plums (0.3 ppm) to harmonize with Canada's MRLs.
A tolerance is not required for dried plums (prune) because this commodity is covered under the plum subgroup 12-12C tolerance.
For strawberry, the Agency is maintaining the existing tolerance to remain harmonized with Codex. Although the Organization for Economic Cooperation and Development (OECD) MRL calculator produces a tolerance of 0.8 ppm for (greenhouse) strawberry, the currently established tolerance level for strawberry (0.60 ppm) is adequate for foliar and greenhouse uses. EPA is revising the strawberry tolerance to 0.6 ppm based on OECD rounding classes.
EPA is establishing tolerances for the tomato subgroup 8-10A at 0.7 ppm and pepper/eggplant subgroup 8-10B at 2 ppm rather than the full crop group vegetable, fruiting, group 8-10 in order to harmonize with the Canadian tolerances on tomato and pepper.
Therefore, tolerances are established for residues of cyflumetofen, (2-methoxyethyl α-cyano-α-[4-(1,1-dimethylethyl)phenyl]-β-oxo-2-(trifluoromethyl)benzenepropanoate), in or on cherry subgroup 12-12A at 1.5 ppm; cucumber at 0.3 ppm; peach subgroup 12-12B at 0.4 ppm; pepper/eggplant subgroup 8-10B at 2 ppm; plum subgroup 12-12C at 0.3 ppm; and tomato subgroup 8-10A at 0.7 ppm.
Additionally, the existing tolerance on tomato is removed as unnecessary due to the establishment of the above tolerances. Also, the existing tolerance for strawberry is modified to 0.6 ppm.
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Start Printed Page 39494Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
2. In § 180.677amend the table in paragraph (a) by:
i. Adding alphabetically the commodities “Cherry subgroup 12-12A”; “Cucumber”; “Peach subgroup 12-12B”; “Pepper/eggplant subgroup 8-10B”; “Plum subgroup 12-12C”; and “Tomato subgroup 8-10A”;
ii. Revise the tolerance entry for “Strawberry”; and
iii. Remove the commodity “Tomato” from the table in paragraph (a).
Cherry subgroup 12-12A 1.5
Cucumber 0.3
Peach subgroup 12-12B 0.4
Pepper/eggplant subgroup 8-10B 2
Plum subgroup 12-12C 0.3
Tomato subgroup 8-10A 0.7
[FR Doc. 2020-13048 Filed 6-30-20; 8:45 am]