Source: https://www.federalregister.gov/documents/2008/03/05/E8-4027/methoxyfenozide-pesticide-tolerances-and-time-limited-pesticide-tolerances
Timestamp: 2018-07-17 18:03:17
Document Index: 87842877

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

Federal Register :: Methoxyfenozide; Pesticide Tolerances and Time-Limited Pesticide Tolerances
Methoxyfenozide; Pesticide Tolerances and Time-Limited Pesticide Tolerances
A Rule by the Environmental Protection Agency on 03/05/2008
This regulation is effective March 5, 2008. Objections and requests for hearings must be received on or before May 5, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
73 FR 11820
11820-11826 (7 pages)
EPA-HQ-OPP-2007-0495
FRL-8352-2
E8-4027
II. Petition for Tolerances
https://www.federalregister.gov/d/E8-4027 https://www.federalregister.gov/d/E8-4027
This regulation establishes tolerances for residues of methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide in or on the food commodities acerola; animal feed, nongrass, group 18, forage; animal feed, nongrass, group 18, hay; avocado; bean, Start Printed Page 11821dry, seed; bushberry subgroup 13-07B; canistel; feijoa; grass, forage, fodder and hay, group 17, forage; grass, forage, fodder and hay, group 17, hay; guava; jaboticaba; kurrat; mango; onion, green, subgroup 3-07B; papaya; passionfruit; peanut; peanut, hay; peanut oil; sapodilla; sapote, black; sapote, mamey; star apple; starfruit; vegetable, tuberous and corm, except potato, sub group 1D; and wax jambu. This regulation also establishes time-limited tolerances for indirect or inadvertent residues of methoxyfenozide; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide and indirect or inadvertent combined residues of methoxyfenozide 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-dimethyl benzoic acid N-tert-butyl-N-[3 ([beta]-D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate of RH 117,236 in or on the food commodities animal feed, nongrass, group 18; grain, cereal, forage, fodder and straw, group 16; grass forage, fodder, and hay, group 17; herb and spice, group 19; vegetable, bulb, group 3-07; vegetable, foliage of legume, group 7; vegetable, leaves of root and tuber, group 2; vegetable, legume, group 6; and vegetable, root and tuber, group 1. Dow AgroSciences LLC and Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). The time-limited tolerances will expire on September 30, 2010.
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0495. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Public Docket, in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
Mark Suarez, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-0120; e-mail address: suarez.mark@epa.gov.
Food manufacturing (NAICS code 311) , e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2007-0495 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before May 5, 2008.
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 that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0495, by one of the following methods:
Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg., 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for Start Printed Page 11822deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
In the Federal Register of October 20, 2006 (71 FR 61971) (FRL-8098-6), August 1, 2007 (72 FR 42072) (FRL-8138-1), and October 24, 2007 (72 FR 60367) (FRL-8154-1), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs 6E7086, 7E7218, 6F7135, and 0F6201) by, Dow AgroSciences LLC, Zionsville Road -Indianapolis, IN 46268 (PPs 6F7135 and 0F6201) and IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 08540 (PPs 7E7218 and 6E7086). The petitions requested that 40 CFR 180.544 be amended by establishing tolerances for residues of the insecticide, methoxyfenozide, in or on the food commodities acerola at 0.4 parts per million (ppm) (PP 7E7218); arionia berry at 3.0 ppm (PP 6E7086); avocado at 0.6 ppm (PP 7E7218); bean, dry, seed at 0.15 ppm (PP 6E7086); blueberry, lowbush at 3.0 ppm (PP 6E7086); buffalo currant at 3.0 ppm (PP 6E7086); bushberry subgroup 13B at 3.0 ppm (PP 6E7086); canistel at 0.6 ppm (PP 7E7218); Chilean guava at 3.0 ppm (PP 6E7086); chive, Chinese, fresh leaves at 5.0 ppm (PP 7E7218); chive, fresh leaves at 5.0 ppm (PP 7E7218); elegans hosta at 5.0 ppm (PP 7E7218); European barberry at 3.0 ppm (PP 6E7086); feijoa at 0.4 ppm (PP 7E7218); fritillaria leaves at 5.0 ppm (PP 7E7218); grass forage, fodder, and hay group 17, forage at 18.0 ppm (PP 6E7086); grass forage, fodder, and hay, group 17, hay at 30.0 ppm (PP 6E7086); guava at 0.4 ppm (PP 7E7218); highbush cranberry at 3.0 ppm (PP 6E7086); honeysuckle at 3.0 ppm (PP 6E7086); jaboticaba at 0.4 ppm (PP 7E7218); jostaberry at 3.0 ppm (PP 6E7086); juneberry at 3.0 ppm (PP 6E7086); kurrat at 5.0 ppm (PP 7E7218); Lady's leek at 5.0 ppm (PP 7E7218); leek at 5.0 ppm (PP 7E7218); leek, wild at 5.0 ppm (PP 7E7218); lingonberry at 3.0 ppm (PP 6E7086); mango at 0.6 ppm (PP 7E7218); native currant at 3.0 ppm (PP 6E7086); nongrass animal feeds, group 18, forage at 35.0 ppm (PP 6F7135); nongrass animal feeds, group 18, hay at 85.0 ppm (PP 6F7135); onion, Beltsville bunching at 5.0 ppm (PP 7E7218); onion, fresh at 5.0 ppm (PP 7E7218); onion, green at 5.0 ppm (PP 7E7218); onion, macrostem at 5.0 ppm (PP 7E7218); onion, tree, tops at 5.0 ppm (PP 7E7218); onion, Welsh, tops at 5.0 ppm (PP 7E7218); papaya at 0.6 ppm (PP 7E7218); passionfruit at 0.4 ppm (PP 7E7218); peanut at 0.02 ppm (PP 6E7086); peanut, hay at 60 ppm (PP 6E7086); peanut oil at 0.09 ppm (PP 6E7086); salal at 3.0 ppm (PP 6E7086); sapodilla at 0.6 ppm (PP 7E7218); sapote, black at 0.6 ppm (PP 7E7218); sapote, mamey at 0.6 ppm (PP 7E7218); sea buckthorn at 3.0 ppm (PP 6E7086); shallot, fresh leaves at 5.0 ppm (PP 7E7218); star apple at 0.6 ppm (PP 7E7218); starfruit at 0.4 ppm (PP 7E7218); vegetable, tuberous and corm, except potato, sub group 1D at 0.02 ppm (PP 6E7086); wax jambu at 0.4 ppm (PP 7E7218). In the petition 0F6201, Dow requested that tolerances that expired on September 30, 2007 be re-established for indirect or inadvertent residues of methoxyfenozide; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide and indirect or inadvertent combined residues of 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-dimethyl benzoic acid N-tert-butyl-N-[3 ([beta]-D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate of RH 117,236 in or on the food commodities grain, cereal, forage, fodder, and straw, group 16 at 10.0 ppm; grass forage, fodder, and hay, group 17 at 10.0 ppm; herb and spice, group 19 at 10.0 ppm; nongrass animal feeds crop group 18 at 10.0 ppm; vegetable, bulb, group 3 at 0.2 ppm; vegetable, foliage of legume, group 7 at 10.0 ppm; vegetable, leaves of root and tuber, group 2 at 0.2 ppm; vegetable, legume, group 6 at 0.1 ppm; and vegetable, root and tuber, group 1 at 0.1 ppm. Those notices referenced summaries of the petitions prepared by Dow AgroSciences LLC and IR-4, the registrants, which are available to the public in the docket, http://www.regulations.gov. Comments were received on the notices of filing. EPA's response to these comments is discussed in Unit IV.C. The time-limited tolerances will expire on September 30, 2010.
Based upon review of the data supporting the petition, EPA has modified the tolerance expression for the food commodities bean, dry, seed to 0.24 ppm (PP 6E7086); animal feeds, nongrass, group 18, forage to 50.0 ppm (PP 6F7135); animal feeds, nongrass, group 18, hay to 150.0 ppm (PP 6F7135); onions, green, subgroup 3-07B at 5.0 ppm (PP 7E7218); peanut, hay to 55 ppm (PP 6E7086); peanut oil to 0.04 ppm (PP 6E7086). The reason for these changes is explained in Unit IV.D. EPA is also deleting all the tolerances in § 180.544(b) for sorghum and soybean commodities that are no longer needed since they have expired. The deletions under § 180.544(b) are time-limited tolerances that were established under section 18 emergency exemptions that have since expired.
Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 408(b)(2) of FFDCA, for tolerances for the petitioned-for tolerances for residues of methoxyfenozide on the food commodities named above. EPA's assessment of exposures and risks associated with establishing the tolerance follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information Start Printed Page 11823concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The toxicology studies conducted with methoxyfenozide demonstrate that it has few or no biologically significant toxic effects at relatively low-dose levels and only mild or no toxic effects at relatively high-dose levels. In subchronic and chronic oral studies in rats, the most toxicologically significant effects were mild anemia and mild effects on the liver, thyroid gland, and adrenal gland. In subchronic and chronic oral studies in dogs, the predominant toxic effect was anemia, which was often accompanied by signs of a compensatory response. Methoxyfenozide is not acutely toxic, not a dermal sensitizer, not neurotoxic, carcinogenic or mutagenic and is not a developmental or reproductive toxicant. There was no evidence for increased susceptibility of rat or rabbit fetuses to in utero exposure or rat pups to post-natal exposure to methoxyfenozide. Minimal or no toxic effects were observed in studies in which methoxyfenozide was administered by the dermal or inhalation routes of exposure. Methoxyfenozide is classified as a “not likely” human carcinogen.
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. The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0495 in that docket.
A summary of the toxicological endpoints for methoxyfenozide used for human risk assessment can be found at http://www.regulations.gov in document “Methoxyfenozide. Human Health Risk Assessment for Proposed Use on Sweet Potato, Blueberry, Dry Bean, Grass, Peanut, Green Onion, Avocado, Guava, Alfalfa and Clover. PC Code:121027, Petition No: 6E7086, 7E7218, and 6F7135. DP Num: 331948, 340540, and 371933” at page 30 in docket ID number EPA-HQ-OPP-2007-0495.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to methoxyfenozide, EPA considered exposure under the petitioned-for tolerances as well as all existing methoxyfenozide tolerances in 40 CFR 180.544. EPA assessed dietary exposures from methoxyfenozide in food as follows:
No such effects were identified in the toxicological studies for methoxyfenozide; 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 USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues.
iii. Cancer. Methoxyfenozide is not likely to be carcinogenic to humans; therefore, a cancer exposure assessment was not conducted.
iv. Anticipated residue and percent crop treated. Anticipated residues/PCT data were not needed to refine the risk assessment so they were not used.
2. Dietary exposure from drinking water. Methoxyfenozide is expected to be a ground water and surface water contaminant primarily due to its persistence in the environment.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations (EECs) of methoxyfenozide for acute exposures are estimated to be 43 parts per billion (ppb) for surface water and 7.43 ppb for ground water. The EECs for chronic exposures are estimated to be 33.1 ppb for surface water and <7.43 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 43 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 33.1 ppb was used to access the contribution to drinking water.
Methoxyfenozide is not registered for use on any sites 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 methoxyfenozide and 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 not assumed that methoxyfenozide has a common Start Printed Page 11824mechanism 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/​pesticides/​cumulative.
1. In general. Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly refered to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is not a concern for prenatal and/or postnatal toxicity resulting from exposure to methoxyfenozide. The prenatal and postnatal toxicology database for methoxyfenozide includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. There was no quantitative or qualitative evidence of increased susceptibility of rats or rabbit fetuses to in utero exposure in the developmental studies; similarly, there was no evidence of increased susceptibility of rat pups following prenatal/postnatal exposure in the 2-generation reproduction study.
3. Conclusion. The FQPA SF for the protection of infants and children be removed (i.e. reduced to 1x) for methoxyfenozide for the following reasons:
i. The toxicology database for methoxyfenozide is complete for assessment of potential hazard to infants and children.
ii. Based on weight-of-the-evidence considerations, EPA determined that a developmental neurotoxicity study in rats is not required to support the registration of methoxyfenozide.
iii. In developmental toxicity studies in rats and rabbits, no increased susceptibility in fetuses as compared to maternal animals was observed following in utero exposures.
iv. In a 2-generation reproduction study in rats, no increased susceptibility in pups as compared to adults was observed following in utero and postnatal exposures.
v. The exposure assessments will not underestimate the potential dietary (food and drinking water) or nondietary exposures for infants and children from the use of methoxyfenozide. The chronic dietary food exposure assessment utilizes tolerance level residues and assumes 100 PCT. Conservative ground water and surface water modeling estimates were used. These assessments will not underestimate the exposure and risks posed by methoxyfenozide.
Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate- and log-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UTs is not exceeded.
1. Acute risk. No acute risk is expected from exposure to methoxyfenozide since no acute endpoints were identified for the general U.S. population (including infants and children) or the females 13-50 years old population subgroup.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to methoxyfenozide from food and water will utilize 56% of the cPAD for the most highly exposed population group, children 1-2 years old. There are no residential uses for methoxyfenozide.
Methoxyfenozide is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water.
Methoxyfenozide is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Methoxyfenozide is classified as a “not likely” human carcinogen and thus 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 methoxyfenozide residues.
Adequate enforcement methodology (high pressure liquid chromatography with mass spectrometry (HPLC/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
There are currently no Codex, Canadian or Mexican MRLs for methoxyfenozide, so there are no international harmonization issues associated with this action.
Public comments were received from a citizen who objected to the proposed tolerances because “methoxyfenozide harms fish and birds so that they die” and also opposes “any exemption or residue left on plants after use from this product.” The comments contained no scientific data or evidence to rebut the Agency's conclusion that there is a reasonable certainty that no harm will result from human or environmental exposure to methoxyfenozide. EPA has responded to similar comments on numerous previous occasions. (January 7, 2005, 70 FR 1349) (October 29, 2004, 69 FR 63083).
The tolerances established here have been modified in some instances from the tolerances originally proposed in the notices of filing. These modifications have been based upon specific data, as described in unit IV.D. The data indicate that the requested tolerance on dry beans at 0.15 ppm is not appropriate Start Printed Page 11825since the field trial data indicate that residues could be higher than the tolerance request. Therefore, a more appropriate tolerance is being established for the residues of methoxyfenozide on bean, dry at 0.24 ppm. The data for peanut hay are adequate. EPA's Review indicates that the requested tolerance of 60 ppm is not appropriate. Therefore, a more appropriate tolerance is being established for the residues of methoxyfenozide on peanut, hay at 55.0 ppm. The data for animal feed, nongrass, group 18, forage and hay are adequate. EPA's Review indicates that the requested tolerances are not appropriate. Residue field trial data from representative crops should be analyzed separately and the highest result used for tolerance setting purposes. This was not done. A more appropriate tolerance is being established for the residues of methoxyfenozide on animal feed, nongrass, group 18, forage at 50 ppm, and hay at 150 ppm. The only processed commodities of regulatory concern for this petition are peanut meal and oil. A study was conducted using a 3x exaggerated application rate to the peanut raw agricultural commodity and simulated commercial processing to produce the peanut processed commodities. Results of the study indicate that residues of methoxyfenozide are not expected to concentrate in peanut meal but do concentrate 3x in oil. The requested tolerance level for peanut oil is inadequate. Using the highest average field trial values from the submitted field trial data and the concentration factor for peanut oil, the tolerance level should be 0.04 ppm.
IR-4 petitioned for individual tolerances on green onion, fresh chive leaves, fresh Chinese chive leaves, elegans hosta, fritillaria leaves, kurrat, Lady's leek, leek, wild leek, Beltsville bunching onion, fresh onion, macrostem onion, tree onion tops, Welsh onion tops, and fresh shallot leaves at 5.0 ppm (PP 7E7128) as well as for a tolerance for bushberry subgroup 13B and individual tolerances on aronia berry, buffalo currant, Chilean guava, European barberry, highbush cranberry, honeysuckle, jostaberry, juneberry, lingonberry, native currant, salal, and sea buckthorn (PP 6E7086).
In the Federal Register of December 7, 2007 (72 FR 69150) (FRL-8340-6), EPA issued a final rule that revised the crop grouping regulations. As part of this action, EPA expanded and revised bulb vegetables group 3. Changes to crop group 3 (bulb vegetables) included adding new commodities, creating subgroups for bulb and green onions, and changing the name of one of the representative commodities from “onion, dry bulb” to “onion, bulb.” EPA also expanded and revised berries group 13. Changes to crop group 13 (berries) included adding new commodities, revising existing subgroups and creating new subgroups (including a bushberry subgroup 13-07B consisting of the commodities requested in PP 6E7086 and cultivars, varieties, and/or hybrids of these).
EPA indicated in the December 7, 2007 final rule as well as the earlier May 23, 2007 proposed rule (72 FR 28920) (FRL-8126-1) that, for existing petitions for which a Notice of Filing had been published, the Agency would attempt to conform these petitions to the rule. Therefore, consistent with this rule, EPA is establishing tolerances on onion, green, subgroup 3-07B and bushberry subgroup 13-07B.
EPA concludes it is reasonable to revise the petitioned-for tolerances so that they agree with the recent crop grouping revisions because:
1. Although the subgroups are new the commodities in the new group were proposed as individual tolerances and the added commodities are closely related minor crops which contribute little to overall dietary or aggregate exposure and risk; and
2. Methoxyfenozide exposure from these added commodities was considered when EPA conducted the dietary and aggregate risk assessments supporting this action.
Therefore, tolerances are established for residues of methoxyfenozide; benzoic acid, 3-methoxy-2-methyl-2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, in or on the food commodities acerola at 0.4 ppm; animal feeds, nongrass, group 18, forage at 50.0 ppm; animal feeds, nongrass, group 18, hay at 150.0 ppm; avocado at 0.6 ppm; bean, dry, seed at 0.24 ppm; bushberry subgroup 13-07B at 3.0 ppm; canistel at 0.6 ppm; feijoa at 0.4 ppm; grass, forage, fodder, and hay group 17, forage at 18.0 ppm; grass, forage, fodder, and hay, group 17, hay at 30.0 ppm; guava at 0.4 ppm; jaboticaba at 0.4 ppm; mango at 0.6 ppm; onions, green, subgroup 3-07B at 5.0 ppm; papaya at 0.6 ppm; passionfruit at 0.4 ppm; peanut at 0.02 ppm; peanut, hay at 55 ppm; peanut oil at 0.04 ppm; sapodilla at 0.6 ppm; sapote, black at 0.6 ppm; sapote, mamey at 0.6 ppm; star apple at 0.6 ppm; starfruit at 0.4 ppm; vegetable, tuberous and corm, except potato, sub group 1D at 0.02 ppm; wax jambu at 0.4 ppm.
Time-limited tolerances are established for the indirect or inadvertent residues for methoxyfenozide in or on vegetable, bulb, group 3 at 0.2 ppm; vegetable, leaves of root and tuber, group 2 at 0.2 ppm; and vegetable, root and tuber, group 1 at 0.1 ppm; and the combined residues of 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-dimethyl benzoic acid N-tert-butyl-N-[3 ([beta]-D-glucopyranosyloxy)-2-methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate of RH 117,236 in or on the food commodities animal feed, nongrass, group 18 at 10.0 ppm; grain, cereal, forage, fodder and straw, group 16 at 10.0 ppm; grass forage, fodder and hay, group 17 at 10.0 ppm; herb and spice, group 19 at 10.0 ppm; vegetable, foliage of legume, group 7 at 10.0 ppm; and vegetable, legume, group 6 at 0.10 ppm.
Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Start Printed Page 11826Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
2. Section 180.544 is amended by:
i. Revising the entries “canistel”; “mango”; “papaya”; “sapodilla”; “sapote, black”; “sapote, mamey”; and “star apple” in paragraph (a)(1).
ii. Alphabetically adding commodities to the table in paragraph (a)(1).
iii. Removing the text from paragraph (b) and reserving the heading.
iv. Revising the tables in paragraphs (d)(1) and (d)(2) to read as follows:
Acerola 0.4
Animal feed, nongrass, group 18, forage 50.0
Animal feed, nongrass, group 18, hay 150.0
Bean, dry, seed 0.24
Bushberry subgroup 13-07B 3.0
Canistel 0.6
Feijoa 0.4
Grass, forage, fodder and hay, group 17, forage 18.0
Grass, forage, fodder and hay, group 17, hay 30.0
Guava 0.4
Jaboticaba 0.4
Mango 0.6
Onion, green, subgroup 3-07B 5.0
Papaya 0.6
Passionfruit 0.4
Peanut, hay 55.0
Peanut, oil 0.04
Sapodilla 0.6
Sapote, black 0.6
Sapote, mamey 0.6
Star apple 0.6
Starfruit 0.4
Vegetable, tuberous and corm, except potato, subgroup 1D 0.02
Wax jambu 0.4
Vegetable, bulb, group 3-07 0.20 9/30/10
Vegetable, leaves of root and tuber, group 2 0.20 9/30/10
Vegetable, root and tuber, group 1 0.10 9/30/10
Animal feed, non-grass, group 18 10.0 9/30/10
Grain, cereal, forage, fodder and straw, group 16 10.0 9/30/10
Grass, forage, fodder and hay, group 17 10.0 9/30/10
Herb and spice, group 19 10.0 9/30/10
Vegetable, foliage of legume, group 7 10.0 9/30/10
Vegetable, legume, group 6 0.10 9/30/10
[FR Doc. E8-4027 Filed 3-4-08; 8:45 am]