Source: https://www.federalregister.gov/documents/2012/07/11/2012-16824/methoxyfenozide-pesticide-tolerances
Timestamp: 2016-09-28 07:05:06
Document Index: 38990413

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

:: Methoxyfenozide; Pesticide Tolerances
A Rule by the Environmental Protection Agency on 07/11/2012
77 FR 40806
40806-40812
EPA-HQ-OPP-2011-0343
FRL-9354-1
Drinking Water Assessment for the IR-4 New Use Petitions for...
Methoxyfenozide. Addendum to Summary fo Analytical Chemistry...
Methoxyfenozide. Petition to Establish Permanent Tolerances...
Methoxyfenozide. Chronic Aggregate Dietary Exposure and Risk...
Methoxyfenozide. Human Health Risk Assessment to Support...
Methoxyfenozide [1E7842] - Company Notice of Filing
https://www.federalregister.gov/d/2012-16824
This regulation establishes tolerances for residues of methoxyfenozide in or on multiple commodities which are identified and discussed later and for indirect or inadvertent combined residues of the methoxyfenozide on various other commodities. In addition, this regulation removes established tolerances for certain commodities/groups superseded by this action and revises the tolerance expression. The Interregional Research Project #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-2011-0343, is available at http://www.regulations.gov or at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, 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-2011-0343 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 10, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0343, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the on line information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E7842) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.544 be amended by establishing tolerances for residues of the insecticide methoxyfenozide (benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl hydrazide), in or on the raw agricultural commodities fruit, citrus, group 10-10 at 1.9 parts per million (ppm); lemon, oil at 45 ppm; citrus, oil (except lemon) at 100 ppm; vegetable, root, except sugar beet, subgroup 1B at 0.8 ppm; and beet, sugar at 0.5 ppm. In addition, the petition proposed that 40 CFR 180.544 be amended by removing the tolerance for vegetable, root, subgroup 1A from paragraph (a) and the tolerances for fruit, citrus and citrus, oil from paragraph (c). Lastly, the petition proposed to revise the tolerance expressions in 40 CFR 180.544. That notice referenced a summary of the petition prepared by Dow AgroSciences LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
In the Federal Register of October 27, 2010 (75 FR 66092) (FRL-8848-3), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7776) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The petition proposed to reestablish tolerances which were inadvertently allowed to expire in 2010. The proposed tolerances in 40 CFR 180.544 are for indirect or inadvertent combined residues of the insecticide methoxyfenozide, (benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) and its metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-dimethylbenzoic acid N-tert-butyl-N′-(3-hydroxy-2-methylbenzoyl) hydrazide, RH-151,055 glucose conjugate of RH-117,236; 3,5-dimethylbenzoic acid N-tert-butyl-N-[3 (β-D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide) and RH-152,072 the malonylglycosyl conjugate of RH-117,236, in or on the raw agricultural commodities: Vegetable, root and tuber, group 1 at 0.1 ppm; vegetable, leaves of root and tuber, group 2 at 0.2 ppm; vegetable, bulb, group 3 at 0.2 ppm; vegetable, legume, group 6 at 0.1 ppm; vegetable, foliage of legume, group 7 at 10 ppm; grain, cereal, forage, fodder, and straw, group 16 at 10 ppm; grass, forage, fodder and hay, group 17 at 10 ppm; animal feed, non-grass, group 18 at 10 ppm; and herb and spice, group 19 at 10 ppm. That notice referenced a summary of the petition prepared by Dow AgroSciences LLC, the 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 petitions, EPA has modified the levels at which tolerances are being established for some of the commodities. The reasons for these changes are explained in Unit IV.C.
Methoxyfenozide is not acutely toxic and not a dermal sensitizer. Minimal or no toxic effects were observed in studies in which methoxyfenozide was administered by the dermal or inhalation routes of exposure. The main target organs in the rat and dog were the liver, thyroid and red blood cells (RBC). The most consistent findings across species and studies were decreased red blood cell parameters and increased liver, thyroid, adrenal and spleen weights. In the rat metabolism study, liver contained 2-9% of the administered radioactivity at maximum concentration (Cmax), but levels decreased and bioaccumulation was not observed. Levels in the blood were negligible. The effects of methoxyfenozide on the blood (methemoglobinemia, decreased red blood cell parameters, Heinz body formation) are consistent with those of other hydrazine compounds.
No maternal or developmental effects were observed in either the rat or rabbit oral developmental toxicity studies. In the rat 2-generation reproductive toxicity study, parental effects were limited to increased liver weight and microscopic periportal hypertrophy. No offspring or reproductive toxicity was observed. In a 28-day dietary immunotoxicity study in the rat, no immunotoxicity was observed. The only observed effect was increased liver weight.
Dermal effects were not observed in the rat following a 28-day exposure period (5 exposure days per week for a total of 20 exposures). This finding is consistent with the relatively low dermal absorption of 2% of the applied dose, observed in an in vivo dermal absorption study in rats treated with an 80% wettable powder (WP) formulation product.
Specific information on the studies received and the nature of the adverse effects caused by methoxyfenozide 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 titled “Methoxyfenozide Human Health Risk Assessment” starting at page 14 in docket ID number EPA-HQ-OPP-2011-0343.
A summary of the toxicological endpoints for methoxyfenozide used for human risk assessment is shown in the Table of this unit.
Table—Summary of Toxicological Doses and Endpoints for Methoxyfenozide for Use in Human Health Risk AssessmentExposure/scenarioPoint of departure and uncertainty/safety factorsRfD, PAD, LOC for risk assessmentStudy and toxicological effectsAcute dietary (General population including infants and children and Females 13-49 years of age)No hazard was identified for a single oral exposure.Chronic dietary (All populations)NOAEL = 10.2 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1xChronic RfD = 0.10 mg/kg/day cPAD = 0.10 mg/kg/dayCo-critical studies: Combined oral chronic toxicity/carcinogenicity-rat LOAEL = 411/491 mg/kg/day M/F based on hematological changes (decreased RBC parameters), periportal liver hypertrophy, thyroid hypertrophy and altered colloid; possibly increased adrenal weight. Chronic oral toxicity-dog NOAEL = 9.8/12.6 mg/kg/day M/F LOAEL = 106.1/110.6 mg/kg/day based on hematological changes (decreased RBC parameters, slight methemoglobinemia) and increased serum bilirubin.Inhalation Short-Term (1-30 days) and Intermediate-Term (1-6 months)NOAEL = 16.8 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1xLOC for MOE = 100Two-week oral range finding study-dog LOAEL = 90.8 mg/kg/day based on hematological changes (decreased RBC parameters, increased Heinz body count, reticulocyte counts, erythrocyte morphology and methemoglobinemia) and increased spleen weights.Cancer (Oral, dermal, inhalation)Classification: Not likely to be carcinogenic to humans.FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies).
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA used tolerance level residues, Dietary Exposure Evaluation Model (DEEM) (Ver. 7.81) default processing factors (as necessary), an empirical processing factor for orange juice, and 100 percent crop treated (PCT) for all commodities.
iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for methoxyfenozide. 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 methoxyfenozide in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of methoxyfenozide. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models the estimated drinking water concentrations (EDWCs) of methoxyfenozide for chronic exposures for non-cancer assessments are estimated to be 43.4 parts per billion (ppb) for surface water and 4.13 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 43.4 ppb was used to assess the contribution to drinking water.
Methoxyfenozide is currently registered for the following uses that could result in residential exposures: Ornamentals. EPA assessed residential exposure using the following assumptions: Adults may be exposed to methoxyfenozide from its currently registered use on ornamentals. Residential pesticide handlers may be exposed for short-term durations of exposure (1-30 days) only. The inhalation (short-term) residential exposure was assessed for a “homeowner” mixer/loader/applicator using a manually pressurized handwand, backpack sprayer, or hose-end sprayer.
4. Cumulative effects from substances with a common mechanism of toxicity.
EPA has not found methoxyfenozide to share a common mechanism of toxicity with any other substances, and methoxyfenozide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that methoxyfenozide 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://www.epa.gov/pesticides/cumulative.
2. Prenatal and postnatal sensitivity. Based on the results in the developmental toxicity studies in rats and rabbits and in the 2-generation reproduction study in rats, no increased sensitivity of fetuses or pups (as compared to adults) was demonstrated for methoxyfenozide. There are no concerns or residual uncertainties for prenatal/postnatal toxicity following exposure to methoxyfenozide.
i. The toxicity database for methoxyfenozide is complete. Although a 28-day inhalation toxicity study has not been submitted, EPA has determined that this study is not needed based on a weight of evidence approach that considered all of the available hazard and exposure information, including the use of a conservative oral POD that results in MOEs ranging from 28,000 to 4,100,000 for risk via the inhalation route due to residential and occupational exposures. Therefore, there is no need for additional UFs to account for missing studies.
ii. There is no indication that methoxyfenozide is a neurotoxic chemical and there is no need for additional UFs to account for neurotoxicity.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment utilized 100 PCT and tolerance-level residues (established or recommended). EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to methoxyfenozide in drinking water. These assessments will not underestimate the exposure and risks posed by methoxyfenozide.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to methoxyfenozide from food and water will utilize 58% 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 methoxyfenozide 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). Methoxyfenozide is currently registered for uses that could result in short-term residential exposure for adults, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to methoxyfenozide.
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 670. Because EPA's level of concern for methoxyfenozide 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). Because no intermediate-term adverse effect was identified, methoxyfenozide is not expected to pose an intermediate-term risk.
Adequate enforcement methodology (high performance liquid chromatography (HPLC), with either tandem mass spectrometric detection (LC/MS/MS) or ultraviolet detection (HPLC/UV)) is available to enforce the tolerance expression.
The Codex has established MRLs for methoxyfenozide in or on citrus fruits at 0.7 ppm, carrots at 0.5 ppm, and radishes at 0.4 ppm. These MRLs are different than the tolerances established for methoxyfenozide in the United States. Harmonization of tolerances in the currently requested commodities is not possible, as the U.S. and Codex use patterns differ potentially resulting in residues in citrus and vegetable, root, except sugar beet, subgroup 1B, which includes carrots and radishes, under U.S. use patterns that are greater than the corresponding Codex MRLs.
EPA is establishing a slightly higher tolerance of 0.90 ppm for vegetable, root, except sugar beet, subgroup 1B, than was proposed. The 0.90 ppm tolerance was calculated using the Organization for Economic Co-operation and Development (OECD) tolerance calculation procedure. Similarly, EPA is establishing tolerances for citrus commodities that are higher than that proposed by IR-4. IR-4 proposed separate tolerances for residues in lemon oil and residues in all other citrus oils. However, because residues from the citrus field trials are similar enough to warrant a crop group tolerance, and a single processing factor was used to derive the oil tolerance, EPA is establishing a conservative tolerance in citrus oil at 100 ppm, and no separate tolerance for residues in lemon oil will be established. Tolerances proposed for inadvertent residues will not be established for vegetable, root and tuber group 1 at 1 ppm since a tolerances exist in § 180.544(a) for subgroups 1A and 1D. Therefore, only a tolerance for potato will be established at the Agency determined level of 0.02 ppm. Tolerances will not be established for vegetable, bulb, group 3 at 0.20 ppm since a tolerance exists in § 180.544(a) for subgroup 3-07B. Only a tolerance for onion, bulb, subgroup 3-07A will be established at the Agency determined level of 0.10 ppm. Tolerances also are not needed for vegetable, legume group 6, grass forage, fodder, and hay group 17, since tolerances for these groups exist under § 180.544(a). Also, since a tolerance exists in § 180.544(a) for coriander, leaves, a tolerance for Herb and spice, group 19, except coriander, leaves will be established at a lower, Agency determined level of 4.5 ppm.
Therefore, tolerances are established for residues of methoxyfenozide (benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimehtylbenzoyl)-2-(1,1-dimethylethyl hydrazide), in or on fruit, citrus, group 10-10 at 3.0 ppm; citrus, oil at 100 ppm; vegetable, root, except sugar beet, subgroup 1B at 0.90 ppm; and beet, sugar 0.50 ppm. Also, due to the tolerances established above by this document, the following existing tolerance is removed as unnecessary; vegetable, root, subgroup 1A. All of the commodities covered by this crop subgroup are covered by the tolerances for vegetable, root, except sugar beet, subgroup 1B, and beet, sugar. In addition, concurrent with the establishment of tolerances for fruit, citrus, group 10-10 at 3.0 ppm and citrus, oil at 100 ppm in § 180.544(a), the tolerances for fruit, citrus, group 10 (10 ppm) and citrus oil (100 ppm) will be removed from § 180.544(c). Tolerances will be established under § 180.544(d)(1) for onion, bulb subgroup 3-07A at 0.10 ppm and for potato at 0.02 ppm. Tolerances will be established under § 180.544(d)(2) for grain, cereal, forage, fodder and straw, group 16 except corn at 6.0 ppm; animal feed, nongrass, group 18, straw at 8.0 ppm; and herb and spice, group 19, except coriander, leaves at 4.5 ppm.
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act
1. The authority citation for part 180 continues to read as follows: Authority:
2. In § 180.544: i. Revise the introductory text in paragraph (a)(1); ii. Remove the entry for “Vegetable, root, subgroup 1A” from the table in paragraph (a)(1), and add alphabetically the following commodities to the table; iii. Revise introductory text in paragraph (a)(2); and iv. Revise paragraphs (b), (c) and (d). The amendments read as follows:
§ 180.544 Methoxyfenozide; tolerances for residues.
(a ) General. (1) Tolerances are established for residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the commodities listed in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only methoxyfenozide (3-methoxy-2-methylbenzoic acid 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or on the commodity.
CommodityParts per million * * * * *Beet, sugar, roots0.50 * * * * *Citrus, oil100 * * * * *Fruit, citrus, group 10-103.0 * * * * *Vegetable, root, except sugar beet, Subgroup 1B0.90 * * * * *
(2) Tolerances are established for residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of methoxyfenozide [3-methoxy-2-methylbenzoic acid 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide] and its glucuronide metabolite (β-D-Glucopyranuronic acid, 3-[[2-(1,1-dimethylethyl)-2-(3,5-dimethylbenzoyl)-hydrazino]carbonyl]-2-methylphenyl-), calculated as the stoichiometric equivalent of methoxyfenozide.
(b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FFIFRA section 18 emergency exemptions. Compliance with the tolerance levels specified in the following table is to be determined by measuring only methoxyfenozide [benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide]. The expired tolerances will be revoked on the date specified in the table.
(d) Indirect or inadvertent tolerances. (1) Tolerances are established for the indirect or inadvertent residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the raw agricultural commodities in the following table, when present therein as a result of the application of methoxyfenozide to growing crops as listed in paragraph (a) of this section. Compliance with the tolerance levels specified in the following table is to be determined by measuring only methoxyfenozide [3-methoxy-2-methylbenzoic acid 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide].
CommodityParts per millionOnion, bulb, subgroup 3-07A0.10Potato0.02
(2) Tolerances are established for the indirect or inadvertent residues of the insecticide methoxyfenozide, including its metabolites and degradates, in or on the raw agricultural commodities in the following table, when present therein as a result of the application of methoxyfenozide to growing crops as listed in paragraph (a) of this section. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of methoxyfenozide [3-methoxy-2-methylbenzoic acid, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide] and the following metabolites (all calculated as the stoichiometric equivalent of methoxyfenozide): free phenol of methoxyfenozide [3,5-dimethylbenzoic acid N-tert-butyl-N′-(3-hydroxy-2-methylbenzoyl) hydrazide], the glucose conjugate of the phenol [3,5-dimethyl benzoic acid N-tert-butyl-N′-[3 (β-D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide] and the malonylglycosyl conjugate of the phenol [3,5-dimethyl benzoic acid N-tert-butyl-N′-[3 (β-D-6-malonyl-glucopyranosyl-1-oxy)-2-methylbenzoyl]-hydrazide].
CommodityParts per millionAnimal feed, nongrass, group 18, straw8.0Grain, cereal, forage, fodder and straw group 16, except corn6.0Herb and spice, group 19, except coriander, leaves4.5
[FR Doc. 2012-16824 Filed 7-10-12; 8:45 am]