Source: http://federal.elaws.us/fr/12/5/2019/2019-26158
Timestamp: 2020-06-03 08:03:21
Document Index: 665476648

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

2019-26158. Etoxazole; Pesticide Tolerances, Federal Register
Home » 2019 Issues » 84 FR (12/05/2019) » 2019-26158. Etoxazole; Pesticide Tolerances
2019-26158. Etoxazole; Pesticide Tolerances
This regulation establishes tolerances for residues of etoxazole in or on beet, sugar, roots and beet, sugar, leaves. The Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective December 5, 2019. Objections and requests for hearings must be received on or before February 3, 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).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2018-0644, 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-2018-0644 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 February 3, 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-2018-0644, by one of the following methods:
In the Federal Register of March 18, 2018 (84 FR 9737) (FRL-9989-71), 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 8E8701) by IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W. Princeton, NJ 08540. The petition requested that 40 CFR part 180.593 be amended by establishing tolerances for residues of the insecticide etoxazole, (2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole), in or on the following sugar beet commodities: Roots at 0.02 parts per million (ppm); dried pulp at 0.04 ppm; and leaves at 1 ppm. In addition, the petition requested tolerances for etoxazole residues in or on the leaves of many other commodities at 1 ppm. That document referenced a summary of the petition prepared by Valent U.S.A. Corporation, Start Printed Page 66627the 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 tolerances that vary from what the petitioner requested, in accordance with section 408(d)(4)(A)(i). The reasons for these changes are explained in Unit IV.C.
The effects in the etoxazole database show liver toxicity in all species tested (enzyme release, hepatocellular swelling and histopathological indicators), and the severity does not appear to increase with time. In rats only, there were effects on incisors (elongation, whitening, and partial loss of upper and/or lower incisors). There is no evidence of neurotoxicity or immunotoxicity. No toxicity was seen at the limit dose in a 28-day dermal toxicity study in rats.
No increased quantitative or qualitative susceptibilities were observed following in utero exposure to rats or rabbits in the developmental studies; however, offspring toxicity was more severe (increased pup mortality) than maternal toxicity (increased liver and adrenal weights) at the same dose (158.7 milligram/kilogram/day (mg/kg/day)) in the rat reproduction study indicating increased qualitative susceptibility. Etoxazole is not mutagenic and not likely to be carcinogenic based on the lack of carcinogenicity effects in the database.
Specific information on the studies received and the nature of the adverse effects caused by etoxazole 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 document, “Etoxazole: Human Health Risk Assessment for Registration Review and a Proposed Section 3 Use on Sugar Beets” at pages 33-37 in docket ID number EPA-HQ-OPP-2018-0644.
Table 1—Summary of Toxicological Doses and Endpoints for Etoxazole for Use in Human Health Risk Assessment
Chronic dietary (All populations) NOAEL= 4.62 mg/kg/day UFA = 10X UFH = 10X FQPA SF = 1X cPAD = cRfD = 0.046 mg/kg/day Chronic Oral Toxicity Study—Dog. LOAEL = 23.5 mg/kg/day based upon increased alkaline phosphatase activity, increased liver weights, liver enlargement (females), and incidences of centrilobular hepatocellular swelling in the liver.
Cancer (Oral, dermal, inhalation) EPA has classified etoxazole as “not likely to be carcinogenic to humans.”
ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID), Version 3.16. This software uses food consumption data from the USDA National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed tolerance-level residues and 100% crop treated (PCT) for all food commodities. EPA's 2018 default processing factors were used except in cases where adequate processing data were available. In the cases where there was no significant concentration, the default processing factors were set to 1.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for etoxazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of etoxazole. 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.
Etoxazole residues of concern in drinking water, which were used in the dietary exposure assessment for this new use, include the parent and two major metabolites, R-8 and R-13. Based on the First Index Reservoir Screening Tool (FIRST), and Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated drinking water concentrations (EDWCs) of etoxazole for chronic exposures are estimated to be 4.761 parts per billion (ppb) for surface water and <0.01 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary exposure and risk assessment, the water concentration of value 4.761 ppb was used to assess the contribution to drinking water.
Etoxazole is not registered for any specific use patterns that would result in residential exposure.
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to etoxazole and any other substances and etoxazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that etoxazole has 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. No increased quantitative or qualitative susceptibilities were observed following in utero exposure to rats or rabbits in the developmental studies. There is evidence of increased qualitative offspring susceptibility in the rat reproduction study, but the concern is low since: (1) The effects in pups are well-characterized with a clear NOAEL; (2) the selected endpoints are protective of the doses where the offspring toxicity is observed; and (3) offspring effects occur in the presence of parental toxicity.
3. Conclusion. Based on the available hazard and exposure database for Start Printed Page 66629etoxazole, EPA recommends that the FQPA SF be reduced to 1X for all exposure scenarios relevant to the current safety assessment.
EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for current exposure scenarios. That decision is based on the following findings:
i. The toxicity database for etoxazole is complete including acceptable developmental toxicity studies in rats and rabbits, a two-generation reproduction study in rats, and acute and subchronic neurotoxicity studies in rats.
ii. There is no evidence of neurotoxicity in the etoxazole database including guideline acute and subchronic neurotoxicity studies.
iii. There are no residual uncertainties for pre- and/or post-natal toxicity. The observed qualitative postnatal susceptibility is protected for by the selected endpoints.
iv. There are no residual uncertainties identified in the exposure databases. Adequate data are available to determine the nature and magnitude of the residue in all proposed/registered crops and in livestock. The current dietary exposure analysis assumed 100 PCT, tolerance-level residues, modeled drinking water estimates, and in the absence of empirical data, default processing factors. Therefore, the dietary exposure analysis is conservative and unlikely to underestimate exposure. There are no registered residential uses for etoxazole.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to etoxazole from food and water will utilize 3.6% of the cPAD for the U.S. population and 15% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for etoxazole.
3. Short- and Intermediate term risks. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Short- and intermediate-term risk is assessed based on short- or intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or 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 short- or intermediate-term risks), no further assessment of short- or intermediate- term risk is necessary. EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for etoxazole.
Adequate enforcement methodology, Valent Method RM-37, gas chromatography/mass-selective detector (GC/MSD) or GC/nitrogen-phosphorus detector (NPD), is available for enforcing the current plant and livestock tolerances.
There are no Codex MRLs for residues of etoxazole in/on sugar beet commodities.
EPA concluded that a separate tolerance for etoxazole residues in or on Beet, sugar, dried pulp is not needed because available processing data indicate that quantifiable residues of etoxazole are unlikely to occur in sugar beet processed commodities following an application at the maximum use rate. In addition, EPA is not establishing any tolerances for residues on plant leaves (other than the tolerance on beet, sugar, leaves) because the petitioner withdrew its request for those tolerances. At this time, those tolerances are not necessary.
Therefore, a tolerance is established for residues of etoxazole, (2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole), in or on Beet, sugar, leaves at 1 ppm and Beet, sugar, roots at 0.02 ppm.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order Start Printed Page 6663013771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
2. In the table in paragraph (a) of § 180.593, add alphabetically the commodities “Beet, sugar, leaves” and “Beet, sugar, roots” to read as follows:
Beet, sugar, leaves 1
[FR Doc. 2019-26158 Filed 12-4-19; 8:45 am]
2019-26158
66626-66630 (5 pages)
EPA-HQ-OPP-2018-0644, FRL-10000-97
2019-26158.pdf
» Etoxazole: Human Health Draft Risk Assessment for Registration Review and a Proposed Section 3 Use on Sugar Beets
» Etoxazole. Addendum to HED’s Risk Assessment of Proposed Section 3 Use on Sugar Beets (D449206)
» Interregional Research Project Number 4 (IR-4) Notice of Filing Pesticide Petition No. 8E8701 establishing a tolerance for residues of the insecticide chemical etoxazole (2(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole)
40 CFR 180.593