Source: https://www.federalregister.gov/documents/2018/06/07/2018-12297/acequinocyl-pesticide-tolerances
Timestamp: 2019-01-23 22:00:12
Document Index: 57430048

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

Federal Register :: Acequinocyl; Pesticide Tolerances
A Rule by the Environmental Protection Agency on 06/07/2018
This regulation is effective June 7, 2018. Objections and requests for hearings must be received on or before August 6, 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 26369
26369-26374 (6 pages)
2018-12297
Acequinocyl in/on Guava and Tropical and Subtropical, Small...
Acequinocyl. Human Health Risk Assessment to Support the...
Acequinocyl: Ecological Risk and Drinking Water Assessments to...
Acequinocyl: Acute and Chronic Aggregate Dietary (Food and...
Interregional Research Project #4 Notice of Filing Pesticide...
https://www.federalregister.gov/d/2018-12297 https://www.federalregister.gov/d/2018-12297
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0376, 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.
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Start Printed Page 26370Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.
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-2017-0376 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 6, 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-2017-0376, by one of the following methods:
In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-9967-37), 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 7E8579) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone (acequinocyl-OH), expressed as acequinocyl equivalents in or on guava at 0.9 ppm and the tropical and subtropical, small fruit, inedible peel, subgroup 24A at 2 ppm. That document referenced a summary of the petition prepared by Arysta LifeScience, the registrant, which is available in the docket, http://www.regulations.gov. A comment expressing concern about the effects of wind turbines on bats was received on the notice of filing, but it is not relevant to this action.
EPA is establishing the requested tolerances with additional significant figures in conformity with Agency policy.
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 tolerances established by this action. EPA's assessment of exposures and risks associated with acequinocyl follows.
The target organs of acequinocyl are the liver (hepatocyte vacuolization, brown pigmented cells and perivascular inflammatory cells in liver) and hematopoietic system (hemorrhage, increased clotting factor times and increased platelet counts). There was no evidence of neurotoxicity or immunotoxicity. There was no evidence of carcinogenic potential in either the rat or mouse and there was no concern for genotoxicity or mutagenicity.
In rats and rabbits, there was no evidence of increased quantitative or qualitative fetal susceptibility. For both species, maternal effects (clinical signs and gross necropsy findings) were observed at similar or lower doses than those producing fetal effects. In rabbits, there were increased incidences of late resorptions at the highest dose tested. Since it is unknown whether resorptions occurred from toxicity to maternal animals or the fetuses, the resorptions are considered maternal and developmental adverse effects. In the rat Start Printed Page 26371two-generation reproduction toxicity study, there was increased quantitative offspring susceptibility. Offspring effects consisted of hemorrhagic effects, swollen body parts (head and extremities), protruding eyes, clinical signs (bloody encrusted nose, cold to touch, red urine, blue colored eyes and extremities, paleness), delays in pupil development, and increased mortality occurring mainly after weaning. The increased incidences of hemorrhagic effects post-weaning indicate toxicity to the hematopoietic system. While there were no parental effects up to the highest dose tested, hematological effects (changes in partial and activated partial thromboplastin times) were observed in adult animals in other studies at the same dose causing the offspring effects, but were not measured in the two-generation reproduction toxicity study. As a result, using a weight-of-evidence approach that considers the findings from the two-generation reproduction toxicity study in context of the full toxicological database, parental toxicity would be anticipated at the same doses as offspring effects if additional evaluations had been performed, particularly hematological measurements. There were no effects on reproductive parameters.
Specific information on the studies received and the nature of the adverse effects caused by acequinocyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 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” on page numbers 29-31 in docket ID number EPA-HQ-OPP-2017-0376.
A summary of the toxicological endpoints for acequinocyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of January 18, 2017 (82 FR 5409) (FRL-9956-85).
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acequinocyl, EPA considered exposure under the petitioned-for tolerances as well as all existing acequinocyl tolerances in 40 CFR 180.599. EPA assessed dietary exposures from acequinocyl in food as follows:
Such effects were identified for acequinocyl. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all proposed and registered uses.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues and 100 PCT for all proposed and registered uses.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that acequinocyl does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for acequinocyl. Tolerance-level residues and 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for acequinocyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of acequinocyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​about-water-exposure-models-used-pesticide.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), Provisional Cranberry Model, and Screening Concentration in Ground Water (SCI-GROW) Model, the estimated drinking water concentrations (EDWCs) of acequinocyl for acute exposures are estimated to be 6.69 parts per billion (ppb) for surface water and 3.6 × 10−3 ppb for ground water, and for chronic exposures are estimated to be 6.69 ppb for surface water and 3.6 × 10−3 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both the acute and chronic dietary risk assessments, the water concentration value of 6.69 ppb was used to assess the contribution to drinking water.
Acequinocyl is currently registered for the following uses that could result in residential exposures: Use on ornamentals for landscapes, gardens, and trees. EPA assessed residential exposure using the following assumptions: Residential handler exposures are not expected since all registered acequinocyl product labels with residential use sites (e.g., ornamentals for landscapes, gardens, and trees) require that handlers wear specific clothing (e.g., long-sleeve shirt/long pants) and/or use personal protective equipment (PPE). As a result, a residential handler assessment was not conducted.Start Printed Page 26372
Only short-term post-application dermal exposure is anticipated for the registered residential uses. The quantitative exposure/risk assessment for residential post-application exposures assessed dermal exposures to adults for activities associated with gardening, dermal exposures to children (6 to <11 years old) for activities associated with playing in and around gardens and gardening, dermal exposures to adults associated with handling trees and retail plants, and dermal exposures to children (6 to <11 years old) for activities associated with playing in and around trees and retail plants.
EPA has not found acequinocyl to share a common mechanism of toxicity with any other substances, and acequinocyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acequinocyl does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​cumulative-assessment-risk-pesticides.
2. Prenatal and postnatal sensitivity. There is no evidence of an increased quantitative or qualitative fetal susceptibility in rats or rabbits. In isolation, there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study; however, the concern is low since:
i. The effects in pups are well characterized with a clear NOAEL and
ii. The effects are protected for by the selected endpoints.
Therefore, there are no residual uncertainties for pre-/post-natal toxicity. Additionally, hematological parameters were not measured for the parental animals in the two-generation reproductive study; however, hematological effects were observed in adult animals in other oral rat studies at the same doses eliciting offspring effects. Therefore, considering the offspring findings in the two-generation reproductive toxicity study in context with the full toxicological database, there is no concern for offspring susceptibility since parental toxicity would be anticipated at the same dose as offspring effects.
i. The toxicity database for acequinocyl is complete.
ii. There is no indication that acequinocyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence of an increased quantitative or qualitative fetal susceptibility in rats or rabbits, but in isolation there was evidence of increased quantitative offspring susceptibility in the two-generation reproductive study. However, the concern is low for the reasons outlined above in section III.D.2.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acequinocyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. These assessments will not underestimate the exposure and risks posed by acequinocyl.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to acequinocyl will occupy 71% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to acequinocyl from food and water will utilize 71% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of acequinocyl is not expected.
3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acequinocyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to acequinocyl.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1140 for adults and 910 for children 6-11 years old. Because EPA's level of concern for acequinocyl is a MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).Start Printed Page 26373
An intermediate-term adverse effect was identified; however, acequinocyl is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for acequinocyl.
5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, acequinocyl is not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, 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 acequinocyl residues.
Adequate enforcement methodology (two high-performance liquid chromatography methods with tandem mass-spectroscopy detection (HPLC/MS/MS) for determining residues in/on fruit and nut commodities (Morse Methods Meth-133, Revision #4 and Meth-135, Revision #3)) is available to enforce the tolerance expression.
The Codex has not established any MRLs for acequinocyl on the crops cited in this document.
Therefore, tolerances are established for residues of acequinocyl, including its metabolites and degradates, in or on guava at 0.90 ppm and the tropical and subtropical, small fruit, inedible peel, subgroup 24A at 2.0 ppm.
2. In § 180.599, add alphabetically the entries “Guava” and “Tropical and subtropical, small fruit, inedible peel, Start Printed Page 26374subgroup 24A” to the table in paragraph (a) to read as follows:
§ 180.599
Guava 0.90
Tropical and subtropical, small fruit, inedible peel, subgroup 24A 2.0
[FR Doc. 2018-12297 Filed 6-6-18; 8:45 am]