Source: https://www.federalregister.gov/documents/2020/05/15/2020-09451/acequinocyl-pesticide-tolerances
Timestamp: 2020-05-31 11:07:45
Document Index: 479764260

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

This regulation is effective May 15, 2020. Objections and requests for hearings must be received on or before July 14, 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).
85 FR 29338
29338-29340 (3 pages)
EPA-HQ-OPP-2019-0387
FRL-10007-38
https://www.federalregister.gov/d/2020-09451 https://www.federalregister.gov/d/2020-09451
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2019-0387, 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-2019-0387 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 July 14, 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 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-2019-0387, by one of the following methods:
In the Federal Register of August 30, 2019 (84 FR 45702) (FRL-9998-15), Start Printed Page 29339EPA 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 9E8768) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4,naphthalenedione and its metabolite 2-dodecyl-3-hydroxy-1,4-naphthoquinone expressed as acequinocyl equivalents in or on the bushberry subgroup 13-07B at 3 parts per million (ppm). That document referenced a summary of the petition prepared by Arysta LifeScience North America Corporation, the registrant, which is available in the docket, http://www.regulations.gov. 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 acequinocyl including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with acequinocyl follows.
On June 7, 2018, EPA published in the Federal Register a final rule establishing tolerances for residues of acequinocyl in or on guava and the tropical and subtropical, small fruit, inedible peel, subgroup 24A based on the Agency's conclusion that aggregate exposure to acequinocyl is safe for the general population, including infants and children. See (83 FR 26369) (FRL-9978-20). That document contains a summary of the toxicological profile and points of departure, assumptions for exposure assessment, and the Agency's determination regarding the children's safety factor, which have not changed.
EPA's exposure assessments have been updated to include the additional exposure from use of acequinocyl on the bushberry subgroup 13-07B, i.e., reliance on tolerance-level residues and an assumption of 100 percent crop treated (PCT). EPA's aggregate exposure assessment incorporated this additional dietary exposure, as well as exposure in drinking water and from residential sources, although those latter exposures are not impacted by the new use on the bushberry subgroup 13-07B and thus have not changed since the last assessment. Further information about EPA's risk assessment and determination of safety supporting the tolerances established in the June 7, 2018 Federal Register action, as well as the new acequinocyl tolerance can be found at http://www.regulations.gov in the document titled “Acequinocyl. Human Health Risk Assessment to Support the Petition for Tolerance for Residues in/on Guava and Tropical and Subtropical, Small Fruit, Inedible Peel, Subgroup 24A.” dated May 16, 2018, in docket ID EPA-HQ-OPP-2017-0376 and the document titled, “Acequinocyl. Human Health Risk Assessment to Support the Petition for Tolerance for Residues in/on the Bushberry Subgroup 13-07B” in docket ID number EPA-HQ-OPP-2019-0387.
Acute dietary risks are below the Agency's level of concern: 58% of the acute population adjusted dose (aPAD) for children 1 to 2 years old, the population group of concern. Chronic dietary risks are below the Agency's level of concern: 54% of the chronic population adjusted dose (cPAD) for children 1 to 2 years old, the group with the highest exposure. There is not expected to be any residential handler exposure, and only post-application dermal exposures are expected from registered uses of acequinocyl in residential areas. Residential post-application oral and inhalation exposures are not expected. Using the exposure assumptions described for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs above the LOC of 100 for all scenarios assessed and are not of concern.
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 acequinocyl residues. More detailed information on the subject action to establish a tolerance in or on the Bushberry subgroup 13-07B can be found in the document entitled, “Acequinocyl. Human Health Risk Assessment to Support the Petition for Tolerance for Residues in/on the Bushberry Subgroup 13-07B” 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-2019-0387.
There are adequate residue analytical methods for enforcing tolerances for acequinocyl residues of concern in/on the registered plant and livestock commodities. These methods include two high-performance liquid chromatography methods with tandem mass-spectroscopy detection (HPLC/MS/MS) for determining residues in/on fruit and nut crops and livestock matrices.
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 Start Printed Page 29340EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for acequinocyl in or on the bushberry subgroup 13-07B.
Therefore, a tolerance is established for residues of acequinocyl, including its metabolites and degradates in or on the bushberry subgroup 13-07B at 3 ppm.
2. In § 180.599, amend the table in paragraph (a) by adding in alphabetical order an entry for “Bushberry subgroup 13-07B” to read as follows:
[FR Doc. 2020-09451 Filed 5-14-20; 8:45 am]