Source: https://www.federalregister.gov/documents/2016/07/27/2016-17786/etoxazole-pesticide-tolerance
Timestamp: 2017-11-23 04:52:00
Document Index: 621966561

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

Federal Register :: Etoxazole; Pesticide Tolerance
This regulation is effective July 27, 2016. Objections and requests for hearings must be received on or before September 26, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
81 FR 49165
49165-49169 (5 pages)
EPA-HQ-OPP-2015-0735
FRL-9948-73
2016-17786
Etoxazole in/on Soybeans. Summary of Analytical Chemistry and...
Etoxazole: Human Health Risk Assessment in Support of Proposed...
Tier I Estimated Drinking Waters Concentrations of Etoxazole,...
Etoxazole. Dietary Risk Assessment in Support of the Proposed...
Valent U.S.A. Corporation Revised March 24, 2016, Notice of...
Valent U.S.A. Corporation Notice of Filing Pesticide Petition...
https://www.federalregister.gov/d/2016-17786 https://www.federalregister.gov/d/2016-17786
This regulation establishes a tolerance for residues of etoxazole in or on soybean seed. Valent U.S.A. Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0735, 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-2015-0735 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 September 26, 2016. 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-2015-0735, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online Start Printed Page 49166instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944-86), 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 5F8398) by Valent U.S.A. Corporation, 1600 Riveira Avenue, Suite 200, Walnut Creek, CA 94596. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the insecticide, etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole, in or on soybean at 0.01 parts per million (ppm). A comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has modified the level at which the tolerance is being established. The reason for this change is explained in Unit IV.D.
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 mg/kg/day) in the rat reproduction study indicating increased qualitative susceptibility. Etoxazole is 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 on pages 20-23 of the document titled “Etoxazole: Human Health Risk Assessment in Support of Proposed Use and Tolerances for Residues of Etoxazole in/on Soybean Seed” in docket ID number EPA-HQ-OPP-2015-0735.
A summary of the toxicological endpoints for etoxazole used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of December 2, 2015 (80 FR 75426) (FRL-9934-60).
No such effects were identified in the toxicological studies for etoxazole; Start Printed Page 49167therefore, a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the 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 or tolerance-level residues adjusted to account for the residues of concern, 100% crop treated (PCT), and in the absence of empirical data, Dietary Exposure Evaluation Model (DEEM) (ver 7.81) default processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that etoxazole 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 percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for etoxazole. Tolerance level residues and 100 PCT were assumed for all food commodities.
Based on the FQPA 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 0.746 ppb for ground water.
EPA has not found etoxazole to share a common mechanism of toxicity with any other substances, and etoxazole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that etoxazole 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 Web site at http://www2.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​cumulative-assessment-risk-pesticides.
3. Short- and Intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermedieate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).Start Printed Page 49168
A short- and intermediate-term adverse effect was identified; however, etoxazole is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. 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 risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for etoxazole.
5. 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 etoxazole residues.
Adequate enforcement methodology (gas chromatography/mass-selective detector (GC/MSD) or GC/nitrogen-phosphorus detector (NPD)) are available to enforce the tolerance expression.
The Codex has not established a MRL for etoxazole in or on soybean seed.
A comment was submitted by the Center for Food Safety and was primarily concerned about environmental risks, including impacts on pollinators and endangered species, and Agency's assessment of the pesticide product under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The comment did not raise any specific issues concerning the safety of etoxazole under the FFDCA. As such, this comment is not relevant to the Agency's evaluation of safety of the etoxazole tolerances; section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment.
The proposed tolerance of 0.01 ppm is below the validated limit of quantification (LOQ) of 0.02 ppm for the analytical method and is therefore being raised to the LOQ level.
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 soybean, seed at 0.02 ppm.
Start List of Subjects Start Printed Page 49169
2. In § 180.593, add alphabetically the commodity “Soybean, seed” to the table in paragraph (a) to read as follows:
Parts (per million)
[FR Doc. 2016-17786 Filed 7-26-16; 8:45 am]