Source: https://www.federalregister.gov/documents/2016/03/08/2016-04740/zoxamide-pesticide-tolerances
Timestamp: 2019-03-20 21:56:07
Document Index: 36354809

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

A Rule by the Environmental Protection Agency on 03/08/2016
This regulation is effective March 8, 2016. Objections and requests for hearings must be received on or before May 9, 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 12011
12011-12015 (5 pages)
EPA-HQ-OPP-2014-0922
FRL-9942-18
2016-04740
Zoxamide. Tolerance Petition for New Uses on Ginseng, Tomato...
Zoxamide. Human Health Aggregate Risk Assessment for the...
Zoxamide: Chronic Aggregate Dietary (Food plus Drinking Water)...
Zoxamide Notice Of Filing Pesticide Petition 4E8335
https://www.federalregister.gov/d/2016-04740 https://www.federalregister.gov/d/2016-04740
This regulation establishes tolerances for residues of zoxamide in or on the tomato subgroup 8-10A, the small, vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F, the tuberous and corm vegetable subgroup 1C and ginseng. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0922, 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.
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Start Printed Page 12012Environmental Protection Agency, 1200 Pennsylvania 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-2014-0922 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 May 9, 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-2014-0922, by one of the following methods:
In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-00), 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 4E8335) 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 residues of the sum of zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide in or on the raw agricultural commodity ginseng at 0.30 parts per million (ppm) and vegetable, tuberous and corm, subgroup 1C at 0.060 ppm. In addition, IR-4 requested to establish tolerances for residues, determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxypropyl)-4- methylbenzamide, in or on the raw agricultural commodity tomato subgroup 8-10A at 2.0 ppm and fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm. IR-4 also proposed, upon the approval of the aforementioned tolerances, to remove established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 ppm. That document referenced a summary of the petition prepared by Gowan Company, 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 zoxamide including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with zoxamide follows.
In repeat dose oral and dermal toxicity studies in rats, there were no indications of systemic toxicity up to the highest dose tested (HDT); most of the highest doses were at or above the limit dose (1,000 milligrams/kilogram/day (mg/kg/day)). In the repeat dose oral toxicity studies in dogs, effects included increased liver and thyroid weights, liver histopathology (i.e., hepatocellular hypertrophy), and increased alkaline phosphatase.Start Printed Page 12013
In the rat and rabbit prenatal developmental toxicity studies, there were no indications of susceptibility, as there was neither maternal nor developmental toxicity up to the HDT. In the rat reproduction study, there were no indications of susceptibility, since parental effects (i.e., decreased maternal body weight) occurred in the absence of reproductive or offspring toxicity.
Zoxamide has been classified as “not likely to be carcinogenic in humans” based on the results of carcinogenicity studies in rats and mice. In the acute and subchronic neurotoxicity studies, there were no indications of neurotoxicity up to the HDT.
Specific information on the studies received and the nature of the adverse effects caused by zoxamide 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 “Zoxamide. Human Health Aggregate Risk Assessment for the Proposed New Uses on Ginseng, Tomato Subgroup 8-10A; Small Fruit, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F; and Tuberous and Corm Vegetable Subgroup 1C” on page 25 in docket ID number EPA-HQ-OPP-2014-0922.
A summary of the toxicological endpoints for zoxamide used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 18, 2014 (79 FR 41911) (FRL-9913-35).
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to zoxamide, EPA considered exposure under the petitioned-for tolerances as well as all existing zoxamide tolerances in 40 CFR 180.567. EPA assessed dietary exposures from zoxamide in food as follows:
No such effects were identified in the toxicological studies for zoxamide; therefore, 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 United States Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) database. As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all established and proposed commodities. The assessment also utilized default processing factors from the Dietary Exposure Evaluation Model—Food Commodity Intake Database (DEEM-FCID) version 7.81 except for raisin and potato granules/flakes, where the processing factor was set at 1.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that zoxamide 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 zoxamide. 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 zoxamide and its major metabolites in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of zoxamide and its metabolites. 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) and Pesticide Root Zone Model Ground Water (PRZM GW) model, the estimated drinking water concentrations (EDWCs) of zoxamide and its major metabolites for chronic exposures are estimated to be 22.84 parts per billion (ppb) for surface water and 65.8 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 65.8 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Zoxamide is not registered for any specific use patterns that would result in residential exposure.
EPA has not found zoxamide to share a common mechanism of toxicity with any other substances, and zoxamide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that zoxamide 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.Start Printed Page 12014
2. Prenatal and postnatal sensitivity. There was no evidence for increased susceptibility following prenatal exposure in prenatal developmental toxicity studies in rats and rabbits. Additionally, there was no evidence for increased susceptibility following pre- or postnatal exposure in the reproduction and fertility effects study in rats.
i. The toxicity database for zoxamide is complete.
ii. There is no indication that zoxamide 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 that zoxamide results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.
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 zoxamide in drinking water. These assessments will not underestimate the exposure and risks posed by zoxamide.
1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, zoxamide is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to zoxamide from food and water will utilize 6.3% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for zoxamide.
A short- and intermediate-term adverse effect was identified; however, zoxamide 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- and 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 zoxamide.
4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, zoxamide is not expected to pose a cancer risk to humans.
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 zoxamide residues.
Adequate enforcement methodology (Gas chromatography with electron capture detection (GC/ECD) and GC with mass selective detection (GC/MSD)) is available to enforce the tolerance expression.
The tolerances being established for the tomato subgroup 8-10A and the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F are harmonized with established Codex MRLs on tomato and grape, respectively. The tolerance being established for the tuberous and corm vegetable subgroup 1C at 0.06 ppm is not harmonized with a Codex MRL on potato at 0.02 ppm. The underlying residue data and residue definition used to support the Subgroup 1C tolerance supports a tolerance recommendation that is higher than the established Codex MRL on potato at 0.02 ppm. There is not a Codex MRL for ginseng.
Therefore, tolerances are established for residues of zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the Start Printed Page 12015stoichiometric equivalent of zoxamide in or on the raw agricultural commodity ginseng at 0.30 ppm and vegetable, tuberous and corm, subgroup 1C at 0.06 ppm. In addition, tolerances are established for residues, determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxypropyl)-4-methylbenzamide, in or on raw agricultural commodity tomato subgroup 8-10A at 2.0 ppm and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm. Lastly, upon the establishment of the aforementioned tolerances, the established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 ppm are removed as unnecessary.
2. In § 180.567:
i. Add alphabetically entries for “Fruit, small vine climbing” and “Tomato subgroup 8-10A”; and
ii. Remove the entries for “Grape” and “Tomato”; and
b. In the table in paragraph (a)(2):
i. Add alphabetically entries for “Ginseng” and “Vegetable, tuberous and corm”; and
ii. Remove the entry “Potato”.
Tomato subgroup 8-10A 2.0
Vegetable, tuberous and corm, subgroup 1C 0.06
[FR Doc. 2016-04740 Filed 3-7-16; 8:45 am]